PROPYLENE GLYCOL
UNII 6DC9Q167V3

Substance Identification & Data

This profile provides standardized clinical and technical data for Propylene Glycol, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 6DC9Q167V3.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 57-55-6 and the RxNorm Concept ID (RxCUI) 34693. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
6DC9Q167V3
CAS Registry Number
57-55-6
RxNorm Concept ID
34693

Detailed Substance Profile

Preferred Name
PROPYLENE GLYCOL
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
6DC9Q167V3
The specific atomic composition represented as a molecular structure string.
InChIKey
C3H8O2
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
DNIAPMSPPWPWGF-UHFFFAOYSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C29388
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
1030
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
OC(CO)C

Synonyms and Nomenclature

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

PROPYLENE GLYCOL

Common Names & Synonyms

E-1520
GLYCEROL IMPURITY C [EP IMPURITY]
INS NO.1520
INS-1520
ISOPROPYLENE GLYCOL
METHYL GLYCOL
PROPYLENE GLYCOL (SOLVENT)
PROPYLENE GLYCOL (SOLVENT) [VANDF]
PROPYLENE GLYCOL [EP MONOGRAPH]
PROPYLENE GLYCOL [FCC]
PROPYLENE GLYCOL [FHFI]
PROPYLENE GLYCOL [HSDB]
PROPYLENE GLYCOL [II]
PROPYLENE GLYCOL [JAN]
PROPYLENE GLYCOL [MART.]
PROPYLENE GLYCOL [MI]
PROPYLENE GLYCOL [USP MONOGRAPH]
PROPYLENE GLYCOL [USP-RS]
PROPYLENE GLYCOL [VANDF]
PROPYLENE GLYCOL [WHO-DD]
PROPYLENE GLYCOL [WHO-IP]
PROPYLENE GLYCOL DL-FORM [MI]
PROPYLENEGLYCOLUM [WHO-IP LATIN]

Brand / Trade Names

CORUM 5117 COMPONENT PROPYLENE GLYCOL
KILFROST ABC-S
KOLLISOLV PG

Systematic Nomenclature

(+/-)-1,2-PROPANEDIOL
(2RS)-PROPANE-1,2-DIOL
1,2-PROPANEDIOL
1,2-PROPYLENE GLYCOL
MONOPROPYLENE GLYCOL
PROPANEDIOL-
PROPYLENE GLYCEROL

Technical Codes

FEMA NO. 2940
NSC-69860

NDC Products Containing PROPYLENE GLYCOL

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. 8
→ Alcon Laboratories, Inc. 17
→ Alcon Research Ltd 1
→ E.R. Squibb & Sons, L.L.C. 3
→ Eli Lilly and Company 3
→ Haleon US Holdings LLC 69
→ Hikma Pharmaceuticals USA 2
→ Hikma Pharmaceuticals USA Inc. 43
→ Hikma Pharmaceuticals USA, Inc. 9
→ Merck Sharp & Dohme LLC 1
→ Novartis Pharmaceuticals Corporation 12
→ Pfizer Laboratories Div Pfizer Inc 15
→ Pharmacia & Upjohn Company LLC 2
→ Viatris Specialty LLC 5
→ Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 10

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
NDC Product
Human Prescription Drug

Zemplar
NDC 0074-1658

Generic Name
Paricalcitol
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Gengraf
NDC 0074-3108

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

Gengraf
NDC 0074-3109

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

Norvir
NDC 0074-3399

Generic Name
Ritonavir
Dosage Form
Powder
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Kaletra
NDC 0074-3956

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

Zemplar
NDC 0074-4637

Generic Name
Paricalcitol
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Kaletra
NDC 0074-6799

Generic Name
Lopinavir And Ritonavir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

Alcon Laboratories, Inc.

NDC Product
Human Otc Drug

Systane Lubricant
NDC 0065-0429

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane
NDC 0065-0454

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Gel
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Complete
NDC 0065-0481

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Ultra
NDC 0065-1431

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Ultra
NDC 0065-1432

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Balance
NDC 0065-1433

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Hydration Pf Preservative Free
NDC 0065-1437

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Day And Night Value Pack
NDC 0065-1502

Generic Name
Polyethylene Glycol 400, Propylene Glycol 0.3%
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Ultra Preservative Free
NDC 0065-1507

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Complete Pf
NDC 0065-1509

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Hydration Pf Preservative Free
NDC 0065-1510

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Complete Pf
NDC 0065-1530

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Complete Pf
NDC 0065-2509

Generic Name
Propylene Glycol Emulsion
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Pro Pf
NDC 0065-3290

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Simbrinza
NDC 0065-4147

Generic Name
Brinzolamide/brimonidine Tartrate
Dosage Form
Suspension/ Drops
Route
Ophthalmic
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Genteal Tears Gel Drops
NDC 0065-8067

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Gel
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Pro Pf
NDC 0065-9308

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing

Alcon Research Ltd

NDC Product
Human Otc Drug

Systane
NDC 0065-0431

Generic Name
Polyethylene Glycol And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
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
NDC Product
Human Prescription Drug

Evista
NDC 0002-4184

Generic Name
Raloxifene Hydrochloride
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Robitussin Day And Night Cough Relief Dm Max
NDC 0031-2834

Generic Name
Dextromethorphan Hydrobromide, Guaifenesin, Doxylamine Succi...
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Bulk Ingredient

NDC 0031-8729

Generic Name
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hy...
Dosage Form
Syrup
Route
N/A
Marketing
EXPORT ONLY
Active Listing
NDC Product
Human Otc Drug

Robitussin Peak Cold Multi-symptom Cold
NDC 0031-8742

Generic Name
Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrin...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Robitussin Long-acting Coughgels
NDC 0031-8743

Generic Name
Dextromethorphan Hydrobromide
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Robitussin Cough Plus Chest Congestion Dm
NDC 0031-8757

Generic Name
Dextromethorphan Hydrobromide And Guaifenesin
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Robitussin Direct Cough
NDC 0031-9302

Generic Name
Dextromethorphan Hydrobromide
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Robitussin Medi-soothers
NDC 0031-9306

Generic Name
Dextromethorphan Hydrobromide, Menthol
Dosage Form
Lozenge
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Robitussin Medi-soothers
NDC 0031-9307

Generic Name
Dextromethorphan Hydrobromide, Menthol
Dosage Form
Lozenge
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Theraflu Severe Cold Relief Nighttime
NDC 0067-0105

Generic Name
Acetaminophen, Diphenhydramine Hcl
Dosage Form
Syrup
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Theraflu Severe Cold Relief
NDC 0067-0107

Generic Name
Acetaminophen, Dextromethorphan Hbr, Diphenphydramine Hcl, G...
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Gas-x Extra Strength
NDC 0067-0117

Generic Name
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 0067-0118

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

Gas-x Extra Strength
NDC 0067-0129

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

Excedrin Extra Strength Pain Reliever
NDC 0067-2001

Generic Name
Acetaminophen, Aspirin (nsaid), And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Extra Strength Headache
NDC 0067-2002

Generic Name
Acetaminophen, Aspirin (nsaid), Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Extra Strength Headache
NDC 0067-2003

Generic Name
Acetaminophen, Aspirin (nsaid), Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Extra Strength Geltabs
NDC 0067-2021

Generic Name
Acetaminophen, Asprin, Caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Migraine Geltabs
NDC 0067-2035

Generic Name
Acetaminophen, Asprin, Caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Excedrin Migraine
NDC 0067-2039

Generic Name
Acetaminophen, Aspirin (nsaid) And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Excedrin Migraine
NDC 0067-2040

Generic Name
Acetaminophen, Aspirin, And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Excedrin Migraine Relief
NDC 0067-2042

Generic Name
Acetaminophen, Aspirin (nsaid), Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Excedrin Pm Triple Action Caplets
NDC 0067-2056

Generic Name
Acetaminophen, Aspirin (nsaid) And Diphenhydramine Citrate
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Theraflu Expressmax Severe Cold And Flu Syrup
NDC 0067-8132

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Syrup
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Tension Headache
NDC 0067-8139

Generic Name
Acetaminophen, Caffeine
Dosage Form
Tablet, Film Coated
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

Theraflu Expressmax Severe Cold And Flu Caplets
NDC 0067-8145

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Voltaren Arthritis Pain
NDC 0067-8152

Generic Name
Diclofenac Sodium
Dosage Form
Gel
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Voltaren Arthritis Pain
NDC 0067-8153

Generic Name
Diclofenac Sodium
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Excedrin Migraine
NDC 0067-8201

Generic Name
Acetaminophen, Aspirin (nsaid) And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Excedrin Extra Strength Pain Reliever
NDC 0067-8202

Generic Name
Acetaminophen, Aspirin (nsaid), And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Extra Strength Pain Reliever
NDC 0067-8203

Generic Name
Acetaminophen, Aspirin (nsaid), And Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Theraflu Flu Relief Max Strength Nighttime
NDC 0067-8205

Generic Name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hb...
Dosage Form
Syrup
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hikma Pharmaceuticals USA

NDC Product
Human Prescription Drug

Methadone Hydrochloride
NDC 0054-0391

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

Methadone Hydrochloride
NDC 0054-0392

Generic Name
Methadone Hydrochloride
Dosage Form
Concentrate
Route
Oral
Marketing
ANDA
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Citalopram
NDC 0054-0062

Generic Name
Citalopram
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
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

Hydromorphone Hydrochloride
NDC 0054-0386

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

Icosapent Ethyl
NDC 0054-0508

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

Dicyclomine Hydrochloride
NDC 0054-0622

Generic Name
Dicyclomine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
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

Aminocaproic Acid
NDC 0054-1100

Generic Name
Aminocaproic Acid
Dosage Form
Syrup
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Alprazolam
NDC 0054-3068

Generic Name
Alprazolam
Dosage Form
Solution, Concentrate
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Diazepam Intensol
NDC 0054-3185

Generic Name
Diazepam Intensol
Dosage Form
Solution, Concentrate
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Diazepam
NDC 0054-3188

Generic Name
Diazepam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Furosemide
NDC 0054-3294

Generic Name
Furosemide
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Furosemide
NDC 0054-3298

Generic Name
Furosemide
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lorazepam
NDC 0054-3532

Generic Name
Lorazepam
Dosage Form
Solution, Concentrate
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Prednisone Intensol
NDC 0054-3721

Generic Name
Prednisone Intensol
Dosage Form
Solution, Concentrate
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Prednisone
NDC 0054-3722

Generic Name
Prednisone
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Propranolol Hydrochloride
NDC 0054-3727

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

Propranolol Hydrochloride
NDC 0054-3730

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

Prednisone
NDC 0054-8724

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

Prednisone
NDC 0054-8739

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

Prednisone
NDC 0054-8740

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

Hikma Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Dexamethasone Intensol
NDC 0054-3176

Generic Name
Dexamethasone Intensol
Dosage Form
Solution, Concentrate
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-3177

Generic Name
Dexamethasone
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-8174

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

Dexamethasone
NDC 0054-8175

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

Dexamethasone
NDC 0054-8176

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

Dexamethasone
NDC 0054-8179

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

Dexamethasone
NDC 0054-8180

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

Dexamethasone
NDC 0054-8181

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

Dexamethasone
NDC 0054-8183

Generic Name
Dexamethasone
Dosage Form
Tablet
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

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Neoral
NDC 0078-0246

Generic Name
Cyclosporine
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Neoral
NDC 0078-0248

Generic Name
Cyclosporine
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Neoral
NDC 0078-0274

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

Trileptal
NDC 0078-0357

Generic Name
Oxcarbazepine
Dosage Form
Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Tegretol
NDC 0078-0508

Generic Name
Carbamazepine
Dosage Form
Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Tegretol
NDC 0078-0509

Generic Name
Carbamazepine
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Tegretol Xr
NDC 0078-0510

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

Tegretol Xr
NDC 0078-0511

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

Tegretol Xr
NDC 0078-0512

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

Rydapt
NDC 0078-0698

Generic Name
Rydapt
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Ilevro
NDC 0078-0743

Generic Name
Nepafenac
Dosage Form
Suspension/ Drops
Route
Ophthalmic
Marketing
NDA
Active Listing
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

Azulfidine En-tabs
NDC 0013-0102

Generic Name
Sulfasalazine
Dosage Form
Tablet, Delayed 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
NDC Product
Human Prescription Drug

Vyndamax
NDC 0069-8730

Generic Name
Tafamidis
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing

Pharmacia & Upjohn Company LLC

NDC Product
Human Prescription Drug

Cleocin T
NDC 0009-3329

Generic Name
Clindamycin Phosphate
Dosage Form
Lotion
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Cleocin
NDC 0009-3448

Generic Name
Clindamycin Phosphate
Dosage Form
Cream
Route
Vaginal
Marketing
NDA
Active Listing

Viatris Specialty LLC

NDC Product
Human Prescription Drug

Elestrin
NDC 0037-4801

Generic Name
Estradiol
Dosage Form
Gel, Metered
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Proctofoam Hc
NDC 0037-6822

Generic Name
Pramoxine Hydrochloride Hydrocortisone Acetate
Dosage Form
Aerosol, Foam
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Proctofoam Ns
NDC 0037-6823

Generic Name
Pramoxine Hydrochloride
Dosage Form
Aerosol, Foam
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Epifoam
NDC 0037-6824

Generic Name
Pramoxine Hydrochloride And Hydrocortisone Acetate
Dosage Form
Aerosol, Foam
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cortifoam
NDC 0037-6830

Generic Name
Hydrocortisone Acetate
Dosage Form
Aerosol, Foam
Route
Topical
Marketing
NDA
Active Listing

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

NDC Product
Human Prescription Drug

Protonix Delayed-release
NDC 0008-0841

Generic Name
Pantoprazole Sodium
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Protonix Delayed-release
NDC 0008-0843

Generic Name
Pantoprazole Sodium
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Protonix Delayed-release
NDC 0008-0844

Generic Name
Pantoprazole Sodium
Dosage Form
Granule, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Duavee
NDC 0008-1123

Generic Name
Conjugated Estrogens/bazedoxifene
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Torisel
NDC 0008-1179

Generic Name
Temsirolimus
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prempro
NDC 0046-1105

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prempro
NDC 0046-1106

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prempro
NDC 0046-1107

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prempro
NDC 0046-1108

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Premphase
NDC 0046-2575

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing

External Clinical & Regulatory Resources

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