SHELLAC
UNII 46N107B71O

Substance Identification & Data

This profile provides standardized clinical and technical data for Shellac, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 46N107B71O.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 9000-59-3 and the RxNorm Concept ID (RxCUI) 1368898. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
46N107B71O
CAS Registry Number
9000-59-3
RxNorm Concept ID
1368898

Detailed Substance Profile

Preferred Name
SHELLAC
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
46N107B71O
The specific atomic composition represented as a molecular structure string.
NCI Thesaurus
C66001
National Cancer Institute reference terminology for clinical and research data.
Substance Type
structurallyDiverse
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
NCBI Taxonomy
473130
Unique numeric identifier used to specify biological species in the NCBI database.

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Shellac. 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

SHELLAC

Common Names & Synonyms

CONFECTIONER'S DEWAXED WHITE LAC GLAZE
KERRIA LACCA RESIN
LAC RESIN
LAC RESIN [II]
LACCIFER LACCA RESIN
LACCOAT 50EDS
MANTROLLAC R 49
MB5IUD6JUA
OPAGLOS
PACRITE APPLE WAX 55
PHARMACEUTICAL GLAZE
PHARMACEUTICAL GLAZE [II]
PHARMACEUTICAL GLAZE [VANDF]
REGULAR BLEACHED SHELLAC
REGULAR BLEACHED SHELLAC [USP-RS]
SHELLAC [EP MONOGRAPH]
SHELLAC [II]
SHELLAC [MART.]
SHELLAC [MI]
SHELLAC [VANDF]
SHELLAC, BLEACHED
SHELLAC, BLEACHED [FCC]
SHELLAC, BLEACHED, WAX-FREE
SHELLAC, BLEACHED, WAX-FREE [FCC]
Z-GBN

Technical Codes

E 904
E-904
INS NO.904
INS-904

NDC Products Containing SHELLAC

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 (500), only Active Listings are currently displayed. Display is limited to the first 200 products.
→ AbbVie Inc. 1
→ Amneal Pharmaceuticals of New York LLC 39
→ C.B. Fleet Company, Inc. 1
→ E.R. Squibb & Sons, L.L.C. 3
→ Eli Lilly and Company 2
→ Genentech, Inc. 7
→ Haleon US Holdings LLC 15
→ Hikma Pharmaceuticals USA Inc. 29
→ L. Perrigo Company 2
→ Merck Sharp & Dohme LLC 7
→ Mission Pharmacal Company 1
→ Novartis Pharmaceuticals Corporation 1
→ Pfizer Laboratories Div Pfizer Inc 14
→ Teva Pharmaceuticals USA, Inc. 78

AbbVie Inc.

NDC Product
Human Prescription Drug

Oriahnn
NDC 0074-1017

Generic Name
Elagolix And Estradiol And Norethisterone
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing

Amneal Pharmaceuticals of New York LLC

NDC Product
Human Prescription Drug

Carvedilol Phosphate
NDC 0115-1248

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

Carvedilol Phosphate
NDC 0115-1249

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

Carvedilol Phosphate
NDC 0115-1250

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

Carvedilol Phosphate
NDC 0115-1251

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

Morphine Sulfate
NDC 0115-1277

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

Morphine Sulfate
NDC 0115-1278

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

Morphine Sulfate
NDC 0115-1279

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

Morphine Sulfate
NDC 0115-1280

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

Morphine Sulfate
NDC 0115-1281

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

Morphine Sulfate
NDC 0115-1282

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

Fenofibric Acid
NDC 0115-1324

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

Fenofibric Acid
NDC 0115-1325

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

Methyltestosterone
NDC 0115-1408

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

Morphine Sulfate
NDC 0115-1479

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

Nitrofurantoin Macrocrystals
NDC 0115-1643

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

Nitrofurantoin Macrocrystals
NDC 0115-1645

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

Dexmethylphenidate Hydrochloride
NDC 0115-1682

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

Dexmethylphenidate Hydrochloride
NDC 0115-1683

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

Dexmethylphenidate Hydrochloride
NDC 0115-1684

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

Dexmethylphenidate Hydrochloride
NDC 0115-1685

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

Dexmethylphenidate Hydrochloride
NDC 0115-1686

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

Dexmethylphenidate Hydrochloride
NDC 0115-1709

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

Dexmethylphenidate Hydrochloride
NDC 0115-1710

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

Acitretin
NDC 0115-1750

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

Acitretin
NDC 0115-1751

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

Acitretin
NDC 0115-1752

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

Acitretin
NDC 0115-1753

Generic Name
Acitretin
Dosage Form
Capsule
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

Dexmethylphenidate Hydrochloride
NDC 0115-9918

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

Dexmethylphenidate Hydrochloride
NDC 0115-9919

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

Dexmethylphenidate Hydrochloride
NDC 0115-9920

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

Dexmethylphenidate Hydrochloride
NDC 0115-9921

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

Dexmethylphenidate Hydrochloride
NDC 0115-9922

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

C.B. Fleet Company, Inc.

NDC Product
Human Otc Drug

Fleet
NDC 0132-0401

Generic Name
Bisacodyl
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

E.R. Squibb & Sons, L.L.C.

NDC Product
Human Prescription Drug

Reyataz
NDC 0003-3622

Generic Name
Atazanavir
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Reyataz
NDC 0003-3631

Generic Name
Atazanavir
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Reyataz
NDC 0003-3638

Generic Name
Atazanavir
Dosage Form
Powder
Route
Oral
Marketing
NDA
Active Listing

Eli Lilly and Company

NDC Product
Human Prescription Drug

Retevmo
NDC 0002-2980

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

Retevmo
NDC 0002-3977

Generic Name
Selpercatinib
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing

Genentech, Inc.

NDC Product
Human Prescription Drug

Cellcept
NDC 0004-0259

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

Cellcept
NDC 0004-0260

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

Cellcept
NDC 0004-0261

Generic Name
Mycophenolate Mofetil
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Cellcept
NDC 0004-0298

Generic Name
Mycophenolate Mofetil Hydrochloride
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Tamiflu
NDC 0004-0800

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

Tamiflu
NDC 0004-0802

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

Tamiflu
NDC 0004-0822

Generic Name
Oseltamivir Phosphate
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
NDA
Active Listing

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Gas-x Total Relief Maximum Strength
NDC 0067-0118

Generic Name
Calcium Carbonate, Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Gas-x Total Relief Maximum Strength
NDC 0067-0119

Generic Name
Calcium Carbonate, Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Perdiem
NDC 0067-8143

Generic Name
Sennosides, Stimulant Laxative
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites
NDC 0135-0183

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Berry Shake
NDC 0135-0184

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Raspberry Lemonade
NDC 0135-0188

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites
NDC 0135-0606

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites
NDC 0135-0618

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Peppermint
NDC 0135-0623

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites With Gas Relief
NDC 0135-0624

Generic Name
Calcium Carbonate And Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Mixed Fruit
NDC 0135-0641

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites Orange And Cream Es
NDC 0135-0642

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Balsalazide Disodium
NDC 0054-0079

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

Calcium Acetate
NDC 0054-0088

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

Ramipril
NDC 0054-0106

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

Ramipril
NDC 0054-0107

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

Ramipril
NDC 0054-0108

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

Ramipril
NDC 0054-0109

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

Mycophenolate Mofetil
NDC 0054-0163

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

Mycophenolate Mofetil
NDC 0054-0166

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

Lisdexamfetamine Dimesylate
NDC 0054-0370

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

Lisdexamfetamine Dimesylate
NDC 0054-0371

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

Lisdexamfetamine Dimesylate
NDC 0054-0372

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

Lisdexamfetamine Dimesylate
NDC 0054-0373

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

Lisdexamfetamine Dimesylate
NDC 0054-0374

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

Lisdexamfetamine Dimesylate
NDC 0054-0375

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

Cyclophosphamide
NDC 0054-0382

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

Cyclophosphamide
NDC 0054-0383

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

Alvimopan
NDC 0054-0668

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

Tapentadol
NDC 0054-0936

Generic Name
Tapentadol Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Tapentadol
NDC 0054-0937

Generic Name
Tapentadol Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Tapentadol
NDC 0054-0938

Generic Name
Tapentadol Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Tapentadol
NDC 0054-0939

Generic Name
Tapentadol Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Tapentadol
NDC 0054-0940

Generic Name
Tapentadol Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Lithium Carbonate
NDC 0054-2526

Generic Name
Lithium Carbonate
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lithium Carbonate
NDC 0054-2527

Generic Name
Lithium Carbonate
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lithium Carbonate
NDC 0054-2531

Generic Name
Lithium Carbonate
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lithium Carbonate
NDC 0054-8526

Generic Name
Lithium Carbonate
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Lithium Carbonate
NDC 0054-8527

Generic Name
Lithium Carbonate
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
NDA
Active Listing

L. Perrigo Company

NDC Product
Human Otc Drug

Good Sense Esomeprazole Magnesium
NDC 0113-0651

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

Good Sense Esomeprazole Magnesium
NDC 0113-0898

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

Merck Sharp & Dohme LLC

NDC Product
Human Prescription Drug

Temodar
NDC 0085-1366

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

Temodar
NDC 0085-1381

Generic Name
Temozolomide
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Temodar
NDC 0085-1417

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

Temodar
NDC 0085-1425

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

Temodar
NDC 0085-1430

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

Temodar
NDC 0085-1519

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

Temodar
NDC 0085-3004

Generic Name
Temozolomide
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing

Mission Pharmacal Company

NDC Product
Human Prescription Drug

Citranatal Assure
NDC 0178-0891

Generic Name
Ascorbic Acid, Calcium Citrate, Iron, Vitamin D, Dl- Alpha- ...
Dosage Form
Kit
Route
N/A
Marketing
UNAPPROVED DRUG OTHER
Active Listing

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Fabhalta
NDC 0078-1189

Generic Name
Iptacopan
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Norpace Cr
NDC 0025-2742

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

Ibrance
NDC 0069-0187

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

Ibrance
NDC 0069-0188

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

Ibrance
NDC 0069-0189

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

Xeljanz Xr
NDC 0069-0501

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

Xeljanz Xr
NDC 0069-0502

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

Sutent
NDC 0069-0550

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

Sutent
NDC 0069-0770

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

Sutent
NDC 0069-0830

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

Sutent
NDC 0069-0980

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

Xeljanz
NDC 0069-1002

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

Xeljanz
NDC 0069-1029

Generic Name
Tofacitinib
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Xalkori
NDC 0069-8140

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

Xalkori
NDC 0069-8141

Generic Name
Crizotinib
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Loperamide Hydrochloride
NDC 0093-0311

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

Piroxicam
NDC 0093-0756

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

Piroxicam
NDC 0093-0757

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

Nortriptyline Hydrochloride
NDC 0093-0810

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

Nortriptyline Hydrochloride
NDC 0093-0811

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

Nortriptyline Hydrochloride
NDC 0093-0812

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

Nortriptyline Hydrochloride
NDC 0093-0813

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

Acitretin
NDC 0093-1135

Generic Name
Acitretin
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-1135

Generic Name
Acitretin
Dosage Form
Capsule
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-1136

Generic Name
Acitretin
Dosage Form
Capsule
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Acitretin
NDC 0093-1136

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

Acitretin
NDC 0093-1138

Generic Name
Acitretin
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-1138

Generic Name
Acitretin
Dosage Form
Capsule
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Amoxicillin
NDC 0093-2267

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

Amoxicillin
NDC 0093-2268

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

Quinine Sulfate
NDC 0093-3002

Generic Name
Quinine Sulfate
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-3002

Generic Name
Quinine Sulfate
Dosage Form
Capsule
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Amoxicillin
NDC 0093-3107

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

Amoxicillin
NDC 0093-3109

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

Dicloxacillin Sodium
NDC 0093-3123

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

Dicloxacillin Sodium
NDC 0093-3125

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

Disopyramide Phosphate
NDC 0093-3127

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

Disopyramide Phosphate
NDC 0093-3129

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

Cefdinir
NDC 0093-3160

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

Cefadroxil
NDC 0093-3196

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

Atomoxetine
NDC 0093-3542

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

Atomoxetine
NDC 0093-3543

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

Atomoxetine
NDC 0093-3544

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

Atomoxetine
NDC 0093-3545

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

Atomoxetine
NDC 0093-3546

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

Atomoxetine
NDC 0093-3547

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

Atomoxetine
NDC 0093-3548

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

Amoxicillin
NDC 0093-4155

Generic Name
Amoxicillin
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexmethylphenidate Hydrochloride
NDC 0093-5045

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

Dexmethylphenidate Hydrochloride
NDC 0093-5046

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

Methylphenidate Hydrochloride (la)
NDC 0093-5346

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

Methylphenidate Hydrochloride (la)
NDC 0093-5347

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

Methylphenidate Hydrochloride (la)
NDC 0093-5348

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

Olanzapine And Fluoxetine
NDC 0093-5503

Generic Name
Olanzapine And Fluoxetine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Olanzapine And Fluoxetine
NDC 0093-5504

Generic Name
Olanzapine And Fluoxetine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Olanzapine And Fluoxetine
NDC 0093-5505

Generic Name
Olanzapine And Fluoxetine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Olanzapine And Fluoxetine
NDC 0093-5506

Generic Name
Olanzapine And Fluoxetine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Olanzapine And Fluoxetine
NDC 0093-5507

Generic Name
Olanzapine And Fluoxetine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Atazanavir Sulfate
NDC 0093-5526

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

Atazanavir Sulfate
NDC 0093-5527

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

Atazanavir Sulfate
NDC 0093-5528

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

Dexmethylphenidate Hydrochloride
NDC 0093-5550

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

Dexmethylphenidate Hydrochloride
NDC 0093-5551

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

Dexmethylphenidate Hydrochloride
NDC 0093-5552

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

Dexmethylphenidate Hydrochloride
NDC 0093-5553

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

Dexmethylphenidate Hydrochloride
NDC 0093-5554

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

Dexmethylphenidate Hydrochloride
NDC 0093-5562

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

Tolterodine Tartrate
NDC 0093-7163

Generic Name
Tolterodine Tartrate
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-7163

Generic Name
Tolterodine Tartrate
Dosage Form
Capsule, Extended Release
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-7164

Generic Name
Tolterodine Tartrate
Dosage Form
Capsule, Extended Release
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Tolterodine Tartrate
NDC 0093-7164

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

Fluoxetine
NDC 0093-7198

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

Mycophenolate Mofetil
NDC 0093-7334

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

Lansoprazole
NDC 0093-7350

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

Lansoprazole
NDC 0093-7351

Generic Name
Lansoprazole
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
NDC Product
Human Prescription Drug

Fluvastatin
NDC 0093-7442

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

Fluvastatin
NDC 0093-7443

Generic Name
Fluvastatin
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-7909

Generic Name
Tiopronin
Dosage Form
Tablet, Sugar Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Tiopronin
NDC 0093-7909

Generic Name
Tiopronin
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Sunitinib Malate
NDC 0093-8199

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

Sunitinib Malate
NDC 0093-8224

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

Sunitinib Malate
NDC 0093-8229

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

Sunitinib Malate
NDC 0093-8231

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

Mexiletine Hydrochloride
NDC 0093-8739

Generic Name
Mexiletine Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-8739

Generic Name
Mexiletine Hydrochloride
Dosage Form
Capsule
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-8740

Generic Name
Mexiletine Hydrochloride
Dosage Form
Capsule
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Mexiletine Hydrochloride
NDC 0093-8740

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

Mexiletine Hydrochloride
NDC 0093-8741

Generic Name
Mexiletine Hydrochloride
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-8741

Generic Name
Mexiletine Hydrochloride
Dosage Form
Capsule
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing

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