DIBUTYL SEBACATE
UNII 4W5IH7FLNY

Substance Identification & Data

This profile provides standardized clinical and technical data for Dibutyl Sebacate, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 4W5IH7FLNY.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 109-43-3 and the RxNorm Concept ID (RxCUI) 1363700. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
4W5IH7FLNY
CAS Registry Number
109-43-3
RxNorm Concept ID
1363700

Detailed Substance Profile

Preferred Name
DIBUTYL SEBACATE
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
4W5IH7FLNY
The specific atomic composition represented as a molecular structure string.
InChIKey
C18H34O4
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
PYGXAGIECVVIOZ-UHFFFAOYSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C76705
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
7986
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
C(=O)(OCCCC)CCCCCCCCC(=O)OCCCC

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Dibutyl Sebacate. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

DIBUTYL SEBACATE

Common Names & Synonyms

DECANEDIOIC ACID, DIBUTYL ESTER
DIBUTYL SEBACATE [FHFI]
DIBUTYL SEBACATE [HSDB]
DIBUTYL SEBACATE [II]
DIBUTYL SEBACATE [MART.]
DIBUTYL SEBACATE [USP-RS]

Systematic Nomenclature

DIBUTYL 1,8-OCTANEDICARBOXYLATE
DIBUTYL DECANEDIOATE

Technical Codes

FEMA NO. 2373
NSC-3893
PX-404

NDC Products Containing DIBUTYL SEBACATE

This unique ingredient identifier is listed as an ingredient or substance in the following products in the NDC directory:

Manufacturer Quick Index

Note: Due to the high number of listings (258), only Active Listings are currently displayed.
→ A-S Medication Solutions 6
→ ANI Pharmaceuticals, Inc. 6
→ Alembic Pharmaceuticals Inc. 4
→ Alembic Pharmaceuticals Limited 4
→ Allergan, Inc. 2
→ American Health Packaging 4
→ Amneal Pharmaceuticals LLC 4
→ Amneal Pharmaceuticals of New York LLC 11
→ Aphena Pharma Solutions - Tennessee, LLC 3
→ Asclemed USA, Inc. 3
→ Aurohealth LLC 2
→ AvKARE 5
→ AvPAK 2
→ Aytu BioPharma, Inc. 6
→ Bausch Health US, LLC 3
→ BluePoint Laboratories 2
→ Bryant Ranch Prepack 4
→ CHAIN DRUG MARKETING ASSOCIATION INC 1
→ Calliditas Therapeutics AB 1
→ Coupler LLC 1
→ DIRECT RX 1
→ Direct_Rx 2
→ Discount Drug Mart, Inc 1
→ Dr. Reddy's Laboratories Inc 1
→ Dr. Reddy's Laboratories Inc. 1
→ Dr. Reddy�s Laboratories Inc. 1
→ Glenmark Pharmaceuticals Inc., USA 2
→ Golden State Medical Supply, Inc. 2
→ HEB 1
→ Ironshore Pharmaceuticals Inc. 5
→ Lannett Company, Inc. 6
→ Lupin Pharmaceuticals, Inc. 12
→ Major Pharmaceuticals 1
→ Medsource Pharmaceuticals 1
→ Mylan Institutional Inc. 3
→ Mylan Pharmaceuticals Inc. 6
→ NuCare Pharmaceuticals, Inc. 1
→ NuCare Pharmaceuticals,Inc. 4
→ Preferred Pharmaceuticals, Inc. 3
→ Proficient Rx LP 6
→ Protega Pharmaceuticals Inc 3
→ QPharma, Inc. 1
→ Quallent Pharmaceuticals Health LLC 2
→ REMEDYREPACK INC. 6
→ SUN PHARMACEUTICAL INDUSTRIES, INC. 1
→ Safecor Health, LLC 2
→ Sandoz Inc 1
→ Sun Pharmaceutical Industries, Inc. 10
→ TRIPOINT THERAPEUTICS, LLC 2
→ Teva Pharmaceuticals USA, Inc. 4
→ Teva Pharmaceuticals, Inc. 1
→ The Kroger Co. 1
→ Upsher-Smith Laboratories, LLC 3
→ WALGREEN CO. 1
→ Walgreens Company 1
→ Zydus Lifesciences Limited 1
→ Zydus Pharmaceuticals USA Inc. 1

A-S Medication Solutions

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 50090-4747

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 50090-4749

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 50090-5107

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 50090-6214

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 50090-6789

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride Xl
NDC 50090-7602

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

ANI Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Tolterodine Tartrate
NDC 43975-322

Generic Name
Tolterodine Tartrate
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tolterodine Tartrate
NDC 43975-323

Generic Name
Tolterodine Tartrate
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Paliperidone
NDC 43975-349

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Paliperidone
NDC 43975-350

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Paliperidone
NDC 43975-351

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Paliperidone
NDC 43975-352

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Alembic Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Paliperidone
NDC 62332-803

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Paliperidone
NDC 62332-804

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Paliperidone
NDC 62332-805

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Paliperidone
NDC 62332-806

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Alembic Pharmaceuticals Limited

NDC Product
Human Prescription Drug

Paliperidone
NDC 46708-803

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Paliperidone
NDC 46708-804

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Paliperidone
NDC 46708-805

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Paliperidone
NDC 46708-806

Generic Name
Paliperidone
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Allergan, Inc.

NDC Product
Human Prescription Drug

Urso 250
NDC 58914-785

Generic Name
Ursodiol
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Urso Forte
NDC 58914-790

Generic Name
Ursodiol
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

American Health Packaging

NDC Product
Human Prescription Drug

Mesalamine
NDC 60687-556

Generic Name
Mesalamine
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Colestipol Hydrochloride
NDC 60687-715

Generic Name
Colestipol Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 60687-782

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 60687-793

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Amneal Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Dexedrine Spansule
NDC 64896-673

Generic Name
Dextroamphetamine Sulfate
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Dexedrine Spansule
NDC 64896-674

Generic Name
Dextroamphetamine Sulfate
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Dexedrine Spansule
NDC 64896-675

Generic Name
Dextroamphetamine Sulfate
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Mesalamine
NDC 65162-360

Generic Name
Mesalamine
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Amneal Pharmaceuticals of New York LLC

NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride
NDC 0115-1736

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride
NDC 0115-1737

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride
NDC 0115-1738

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride
NDC 0115-1739

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride
NDC 0115-1740

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride
NDC 0115-1741

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Colestipol Hydrochloride
NDC 0115-5211

Generic Name
Colestipol Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tamsulosin Hydrochloride
NDC 0115-8211

Generic Name
Tamsulosin Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dextroamphetamine Sulfate Extended-release
NDC 0115-9927

Generic Name
Dextroamphetamine Sulfate
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Dextroamphetamine Sulfate Extended-release
NDC 0115-9928

Generic Name
Dextroamphetamine Sulfate
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Dextroamphetamine Sulfate Extended-release
NDC 0115-9929

Generic Name
Dextroamphetamine Sulfate
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing

Aphena Pharma Solutions - Tennessee, LLC

NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 71610-030

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Omeprazole
NDC 71610-688

Generic Name
Omeprazole
Dosage Form
Capsule, Delayed Release Pellets
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 71610-707

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Asclemed USA, Inc.

NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 76420-536

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 76420-537

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 76420-538

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Aurohealth LLC

NDC Product
Human Otc Drug

Pseudoephedrine Hydrochloride
NDC 58602-884

Generic Name
Pseudoephedrine Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

AvKARE

NDC Product
Human Prescription Drug

Mesalamine
NDC 42291-489

Generic Name
Mesalamine
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 42291-897

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 42291-898

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 42291-899

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tamsulosin Hydrochloride
NDC 42291-989

Generic Name
Tamsulosin Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

AvPAK

NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 50268-133

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 50268-134

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Aytu BioPharma, Inc.

NDC Product
Human Prescription Drug

Metadate Cd
NDC 69654-579

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Metadate Cd
NDC 69654-580

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Metadate Cd
NDC 69654-581

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Metadate Cd
NDC 69654-582

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Metadate Cd
NDC 69654-583

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Metadate Cd
NDC 69654-584

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA
Active Listing

Bausch Health US, LLC

NDC Product
Human Prescription Drug

Aplenzin
NDC 0187-5810

Generic Name
Bupropion Hydrobromide
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Aplenzin
NDC 0187-5811

Generic Name
Bupropion Hydrobromide
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Aplenzin
NDC 0187-5812

Generic Name
Bupropion Hydrobromide
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
NDA
Active Listing

BluePoint Laboratories

NDC Product
Human Prescription Drug

Ursodiol
NDC 68001-377

Generic Name
Ursodiol
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ursodiol
NDC 68001-378

Generic Name
Ursodiol
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Bryant Ranch Prepack

NDC Product
Human Prescription Drug

Metformin Hydrochloride
NDC 63629-5934

Generic Name
Metformin Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 63629-8319

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 63629-8323

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 71335-9670

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

CHAIN DRUG MARKETING ASSOCIATION INC

NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 63868-425

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Calliditas Therapeutics AB

NDC Product
Human Prescription Drug

Tarpeyo
NDC 81749-004

Generic Name
Budesonide
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
NDA
Active Listing

Coupler LLC

NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 67046-1527

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

DIRECT RX

NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 72189-154

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Direct_Rx

NDC Product
Human Prescription Drug

Bupropion Hcl Er (xl)
NDC 61919-558

Generic Name
Bupropion Hcl Er (xl)
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hcl Er
NDC 72189-521

Generic Name
Tramadol Hcl Er
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Discount Drug Mart, Inc

NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 53943-527

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Dr. Reddy's Laboratories Inc

NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 43598-407

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Dr. Reddy's Laboratories Inc.

NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 43598-812

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Dr. Reddy�s Laboratories Inc.

NDC Product
Drug For Further Processing

NDC 43598-407

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing

Glenmark Pharmaceuticals Inc., USA

NDC Product
Human Prescription Drug

Ursodiol
NDC 68462-473

Generic Name
Ursodiol
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ursodiol
NDC 68462-474

Generic Name
Ursodiol
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Golden State Medical Supply, Inc.

NDC Product
Human Prescription Drug

Tolterodine Tartrate
NDC 51407-739

Generic Name
Tolterodine Tartrate
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tolterodine Tartrate
NDC 51407-740

Generic Name
Tolterodine Tartrate
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

HEB

NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 37808-115

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Ironshore Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Jornay Pm Extended-release
NDC 71376-201

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Jornay Pm Extended-release
NDC 71376-202

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Jornay Pm Extended-release
NDC 71376-203

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Jornay Pm Extended-release
NDC 71376-204

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Jornay Pm Extended-release
NDC 71376-205

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing

Lannett Company, Inc.

NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride Cd
NDC 0527-4579

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride Cd
NDC 0527-4580

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride Cd
NDC 0527-4581

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride Cd
NDC 0527-4582

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride Cd
NDC 0527-4583

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Methylphenidate Hydrochloride Cd
NDC 0527-4584

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing

Lupin Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Fenofibric Acid
NDC 68180-128

Generic Name
Fenofibric Acid
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Fenofibric Acid
NDC 68180-129

Generic Name
Fenofibric Acid
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride Xl
NDC 68180-319

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride Xl
NDC 68180-320

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Metformin Hydrochloride
NDC 68180-336

Generic Name
Metformin Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Metformin Hydrochloride
NDC 68180-337

Generic Name
Metformin Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 68180-383

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 68180-384

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 68180-385

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 68180-697

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 68180-698

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 68180-699

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Major Pharmaceuticals

NDC Product
Human Prescription Drug

Bupropion Hydrochloride Xl
NDC 0904-7469

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Medsource Pharmaceuticals

NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 45865-184

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Mylan Institutional Inc.

NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 51079-766

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 51079-767

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Verapamil Hydrochloride
NDC 51079-917

Generic Name
Verapamil Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Mylan Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 0378-0472

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 0378-0473

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Verapamil Hydrochloride
NDC 0378-6320

Generic Name
Verapamil Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Verapamil Hydrochloride
NDC 0378-6380

Generic Name
Verapamil Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Verapamil Hydrochloride
NDC 0378-6440

Generic Name
Verapamil Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ketoprofen
NDC 0378-8200

Generic Name
Ketoprofen
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

NuCare Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Bupropion Hydrochloride Xl
NDC 68071-3932

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

NuCare Pharmaceuticals,Inc.

NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 68071-1671

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 68071-3559

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride Xl
NDC 68071-3928

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 68071-5078

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Preferred Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 68788-7601

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 68788-8367

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Metformin Hydrochloride
NDC 68788-8520

Generic Name
Metformin Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Proficient Rx LP

NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 63187-177

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 63187-420

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 63187-481

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 71205-463

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 71205-468

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 71205-569

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Protega Pharmaceuticals Inc

NDC Product
Human Prescription Drug

Roxybond
NDC 81140-101

Generic Name
Oxycodone Hydrochloride
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Roxybond
NDC 81140-102

Generic Name
Oxycodone Hydrochloride
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Roxybond
NDC 81140-103

Generic Name
Oxycodone Hydrochloride
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing

QPharma, Inc.

NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 42708-054

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Quallent Pharmaceuticals Health LLC

NDC Product
Human Prescription Drug

Bupropion Hydrochloride Xl
NDC 82009-051

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride Xl
NDC 82009-052

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

REMEDYREPACK INC.

NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 70518-0886

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 70518-0942

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 70518-2022

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Tramadol Hydrochloride
NDC 70518-2795

Generic Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Metformin Hydrochloride
NDC 70518-4369

Generic Name
Metformin Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride Xl
NDC 70518-4446

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

SUN PHARMACEUTICAL INDUSTRIES, INC.

NDC Product
Human Prescription Drug

Aspruzyo Sprinkle
NDC 47335-625

Generic Name
Ranolazine
Dosage Form
Granule
Route
Oral
Marketing
NDA
Active Listing

Safecor Health, LLC

NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 48433-033

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 48433-034

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Sandoz Inc

NDC Product
Human Prescription Drug

Omeprazole
NDC 0781-2234

Generic Name
Omeprazole
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Sun Pharmaceutical Industries, Inc.

NDC Product
Human Prescription Drug

Metformin Hydrochloride
NDC 47335-305

Generic Name
Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Metformin Hydrochloride
NDC 47335-306

Generic Name
Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 47335-758

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 47335-759

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 47335-760

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupropion Hydrochloride
NDC 47335-954

Generic Name
Bupropion Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

TRIPOINT THERAPEUTICS, LLC

NDC Product
Human Prescription Drug

Elepsia Xr 1000 Mg
NDC 80705-100

Generic Name
Levetiracetam
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Elepsia Xr 1500 Mg
NDC 80705-101

Generic Name
Levetiracetam
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
NDA
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Mesalamine
NDC 0093-5907

Generic Name
Mesalamine
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 0093-7384

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 0093-7385

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Venlafaxine Hydrochloride
NDC 0093-7386

Generic Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Teva Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Mesalamine
NDC 0480-7750

Generic Name
Mesalamine
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

The Kroger Co.

NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 30142-261

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Upsher-Smith Laboratories, LLC

NDC Product
Human Prescription Drug

Diltiazem Hydrochloride
NDC 24979-181

Generic Name
Diltiazem Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Diltiazem Hydrochloride
NDC 24979-182

Generic Name
Diltiazem Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Diltiazem Hydrochloride
NDC 24979-183

Generic Name
Diltiazem Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

WALGREEN CO.

NDC Product
Human Otc Drug

Pseudoephedrine Hydrochloride
NDC 0363-6611

Generic Name
Pseudoephedrine Hydrochloride
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

Walgreens Company

NDC Product
Human Otc Drug

Esomeprazole Magnesium
NDC 0363-3298

Generic Name
Esomeprazole Magnesium
Dosage Form
Capsule, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Zydus Lifesciences Limited

NDC Product
Human Prescription Drug

Sevelamer Carbonate
NDC 70771-1520

Generic Name
Sevelamer Carbonate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Zydus Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Sevelamer Carbonate
NDC 68382-824

Generic Name
Sevelamer Carbonate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

External Clinical & Regulatory Resources

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