POLYETHYLENE GLYCOL, UNSPECIFIED
UNII 3WJQ0SDW1A

Substance Identification & Data

This profile provides standardized clinical and technical data for Polyethylene Glycol, Unspecified, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 3WJQ0SDW1A.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 25322-68-3 and the RxNorm Concept ID (RxCUI) 8516. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
3WJQ0SDW1A
CAS Registry Number
25322-68-3
RxNorm Concept ID
8516

Detailed Substance Profile

Preferred Name
POLYETHYLENE GLYCOL, UNSPECIFIED
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
3WJQ0SDW1A
The specific atomic composition represented as a molecular structure string.
NCI Thesaurus
C762
National Cancer Institute reference terminology for clinical and research data.
INN ID
169
Sequential identifier assigned via the WHO International Nonproprietary Name program.
Substance Type
mixture
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Polyethylene Glycol, Unspecified. 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

MACROGOL

Common Names & Synonyms

MACROGOL [INN]
MACROGOL [WHO-DD]
MACROGOLS
MACROGOLS [EP MONOGRAPH]
PEG
POLY(OXY-1,2-ETHANEDIYL, .ALPHA.-HYDRO-.OMEGA.-HYDROXY-
POLYETHYLENE GLYCOL
POLYETHYLENE GLYCOL [VANDF]
POLYETHYLENE GLYCOL 300-1600
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYETHYLENE GLYCOLS
POLYETHYLENE GLYCOLS [FCC]
POLYETHYLENE OXIDE
POLYETHYLENE OXIDE [USP-RS]
POLYETHYLENE OXIDES
POLYOXYETHYLENE
POLYOXYETHYLENE [VANDF]

Technical Codes

E-1521
INS NO.1521
INS-1521

NDC Products Containing POLYETHYLENE GLYCOL, UNSPECIFIED

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. 15
→ Alcon Laboratories, Inc. 3
→ Alcon Research Ltd 1
→ Allergan, Inc. 1
→ E.R. Squibb & Sons, L.L.C. 7
→ Eli Lilly and Company 6
→ Haleon US Holdings LLC 37
→ Hikma Pharmaceuticals USA Inc 1
→ Hikma Pharmaceuticals USA Inc. 10
→ L. Perrigo Company 37
→ Merck Sharp & Dohme LLC 6
→ Novartis Pharmaceuticals Corporation 19
→ Parke-Davis Div of Pfizer Inc 1
→ Pfizer Laboratories Div Pfizer Inc 17
→ Pharmacia & Upjohn Company LLC 1
→ Roerig 1
→ Sanofi-Aventis U.S. LLC 2
→ Teva Pharmaceuticals USA, Inc. 27
→ Viatris Specialty LLC 1
→ Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 3
→ sanofi-aventis U.S. LLC 4

AbbVie Inc.

NDC Product
Human Prescription Drug

Creon
NDC 0032-1203

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

Creon
NDC 0032-1206

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

Creon
NDC 0032-1212

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

Creon
NDC 0032-1224

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

Creon
NDC 0032-3016

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

Orilissa
NDC 0074-0038

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

Orilissa
NDC 0074-0039

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

Venclexta
NDC 0074-0561

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

Venclexta
NDC 0074-0566

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

Venclexta
NDC 0074-0576

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

Venclexta
NDC 0074-0579

Generic Name
Venetoclax
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing
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

Rinvoq
NDC 0074-2306

Generic Name
Upadacitinib
Dosage Form
Tablet, Extended Release
Route
Oral
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

Alcon Laboratories, Inc.

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 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 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

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

Allergan, Inc.

NDC Product
Human Prescription Drug

Durysta
NDC 0023-9652

Generic Name
Bimatoprost
Dosage Form
Implant
Route
Intracameral
Marketing
NDA
Active Listing

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

NDC Product
Human Prescription Drug

Sprycel
NDC 0003-0524

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

Sprycel
NDC 0003-0527

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

Sprycel
NDC 0003-0528

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

Sprycel
NDC 0003-0852

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

Sprycel
NDC 0003-0855

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

Sprycel
NDC 0003-0857

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

Sotyktu
NDC 0003-0895

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

Eli Lilly and Company

NDC Product
Human Prescription Drug

Olumiant
NDC 0002-4182

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

Verzenio
NDC 0002-4483

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

Olumiant
NDC 0002-4732

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

Verzenio
NDC 0002-4815

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

Verzenio
NDC 0002-5337

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

Verzenio
NDC 0002-6216

Generic Name
Abemaciclib
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
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

Excedrin Rapid Relief
NDC 0067-2200

Generic Name
Acetaminophen
Dosage Form
Tablet
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

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

Hikma Pharmaceuticals USA Inc

NDC Product
Human Prescription Drug

Vigabatrin
NDC 0054-0652

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

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Lithium Carbonate
NDC 0054-0021

Generic Name
Lithium Carbonate
Dosage Form
Tablet, Extended Release
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

Tapentadol
NDC 0054-0942

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

Tapentadol
NDC 0054-0943

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

Tapentadol
NDC 0054-0945

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

Lorazepam
NDC 0054-3532

Generic Name
Lorazepam
Dosage Form
Solution, Concentrate
Route
Oral
Marketing
ANDA
Active Listing

L. Perrigo Company

NDC Product
Human Otc Drug

Good Sense Pain Relief
NDC 0113-0025

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

Good Sense Ibuprofen Pm
NDC 0113-0050

Generic Name
Diphenhydramine Citrate, Ibuprofen
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Suphedrine 12 Hour
NDC 0113-0054

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

Good Sense Night Time
NDC 0113-0056

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

Good Sense Acid Reducer
NDC 0113-0141

Generic Name
Famotidine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense All Day Allergy D
NDC 0113-0147

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

Good Sense Acid Reducer
NDC 0113-0194

Generic Name
Famotidine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Anti Diarrheal
NDC 0113-0224

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

Good Sense Levocetirizine
NDC 0113-0241

Generic Name
Levocetirizine Dihydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Ibuprofen
NDC 0113-0298

Generic Name
Ibuprofen
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nasal
NDC 0113-0304

Generic Name
Oxymetazoline Hydrochloride
Dosage Form
Spray
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Night Time
NDC 0113-0335

Generic Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nasal
NDC 0113-0388

Generic Name
Oxymetazoline Hcl
Dosage Form
Spray, Metered
Route
Nasal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Zephrex D
NDC 0113-0401

Generic Name
Pseudoephedrine Hydrochloride
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nighttime Sleep Aid
NDC 0113-0431

Generic Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nasal Decongestant
NDC 0113-0432

Generic Name
Pseudoephedrine Hcl
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Pain Relief Pm Extra Strength
NDC 0113-0437

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

Good Sense Nighttime
NDC 0113-0459

Generic Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Allergy Relief
NDC 0113-0479

Generic Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Pain Relief
NDC 0113-0484

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

Good Sense Stool Softener
NDC 0113-0486

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

Good Sense Ibuprofen
NDC 0113-0517

Generic Name
Ibuprofen
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Pain Relief Arthritis Pain
NDC 0113-0544

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

Good Sense Severe Daytime Cold And Flu
NDC 0113-0603

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

Good Sense Ibuprofen
NDC 0113-0604

Generic Name
Ibuprofen
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Ibuprofen
NDC 0113-0647

Generic Name
Ibuprofen
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
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 Daytime Non Drowsy Cold And Flu
NDC 0113-0656

Generic Name
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Aller Ease
NDC 0113-0847

Generic Name
Fexofenadine Hydrochloride
Dosage Form
Tablet, Film Coated
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
NDC Product
Human Otc Drug

Good Sense Naproxen Sodium
NDC 0113-0901

Generic Name
Naproxen Sodium
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Tussin Dm Max
NDC 0113-0927

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

Good Sense Daytime
NDC 0113-0994

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

Good Sense Lansoprazole
NDC 0113-1114

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

Good Sense Ibuprofen
NDC 0113-1212

Generic Name
Ibuprofen
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Naproxen Sodium
NDC 0113-1412

Generic Name
Naproxen Sodium
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Pain Relief
NDC 0113-1889

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

Merck Sharp & Dohme LLC

NDC Product
Human Prescription Drug

Januvia
NDC 0006-0112

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

Januvia
NDC 0006-0221

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

Januvia
NDC 0006-0277

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

Janumet
NDC 0006-0575

Generic Name
Sitagliptin And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Janumet
NDC 0006-0577

Generic Name
Sitagliptin And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Welireg
NDC 0006-5331

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

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Femara
NDC 0078-0249

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

Diovan Hct
NDC 0078-0314

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

Diovan Hct
NDC 0078-0315

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

Trileptal
NDC 0078-0337

Generic Name
Oxcarbazepine
Dosage Form
Tablet, Film Coated
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

Diovan Hct
NDC 0078-0383

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

Trileptal
NDC 0078-0456

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

Trileptal
NDC 0078-0457

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

Diovan Hct
NDC 0078-0471

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

Diovan Hct
NDC 0078-0472

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

Exforge
NDC 0078-0488

Generic Name
Amlodipine Besylate And Valsartan
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Exforge
NDC 0078-0489

Generic Name
Amlodipine Besylate And Valsartan
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Exforge
NDC 0078-0490

Generic Name
Amlodipine Besylate And Valsartan
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Exforge
NDC 0078-0491

Generic Name
Amlodipine Besylate And Valsartan
Dosage Form
Tablet, Film Coated
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

Tykerb
NDC 0078-0671

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

Vanrafia
NDC 0078-1420

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

Parke-Davis Div of Pfizer Inc

NDC Product
Human Prescription Drug

Lopid
NDC 0071-0737

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

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Lorbrena
NDC 0069-0227

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

Lorbrena
NDC 0069-0231

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

Cibinqo
NDC 0069-0235

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

Toviaz
NDC 0069-0242

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

Toviaz
NDC 0069-0244

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

Daurismo
NDC 0069-0298

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

Cibinqo
NDC 0069-0335

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

Cibinqo
NDC 0069-0435

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

Chantix
NDC 0069-0468

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

Chantix
NDC 0069-0469

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

Chantix
NDC 0069-0471

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

Daurismo
NDC 0069-1531

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

Procardia Xl
NDC 0069-2650

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

Procardia Xl
NDC 0069-2660

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

Paxlovid
NDC 0069-5045

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

Paxlovid
NDC 0069-5317

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

Paxlovid
NDC 0069-5321

Generic Name
Nirmatrelvir And Ritonavir
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing

Pharmacia & Upjohn Company LLC

NDC Product
Human Prescription Drug

Depo-subq Provera
NDC 0009-4709

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
NDA
Active Listing

Roerig

NDC Product
Human Prescription Drug

Glucotrol Xl
NDC 0049-0178

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

Sanofi-Aventis U.S. LLC

NDC Product
Human Prescription Drug

Avalide
NDC 0024-5855

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

Avalide
NDC 0024-5856

Generic Name
Irbesartan And Hydrochlorothiazide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Diltiazem Hydrochloride
NDC 0093-0318

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

Diltiazem Hydrochloride
NDC 0093-0319

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

Diltiazem Hydrochloride
NDC 0093-0320

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

Diltiazem Hydrochloride
NDC 0093-0321

Generic Name
Diltiazem Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-3241

Generic Name
Bisoprolol Fumarate And Hydrochlorothiazide
Dosage Form
Tablet, Film Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Bisoprolol Fumarate And Hydrochlorothiazide
NDC 0093-3241

Generic Name
Bisoprolol Fumarate And Hydrochlorothiazide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-3242

Generic Name
Bisoprolol Fumarate And Hydrochlorothiazide
Dosage Form
Tablet, Film Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Bisoprolol Fumarate And Hydrochlorothiazide
NDC 0093-3242

Generic Name
Bisoprolol Fumarate And Hydrochlorothiazide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-3243

Generic Name
Bisoprolol Fumarate And Hydrochlorothiazide
Dosage Form
Tablet, Film Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Bisoprolol Fumarate And Hydrochlorothiazide
NDC 0093-3243

Generic Name
Bisoprolol Fumarate And Hydrochlorothiazide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Cyclobenzaprine Hydrochloride
NDC 0093-3420

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

Cyclobenzaprine Hydrochloride
NDC 0093-3421

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

Cyclobenzaprine Hydrochloride
NDC 0093-3422

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

Rivelsa
NDC 0093-6031

Generic Name
Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol
Dosage Form
Kit
Route
N/A
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-8117

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

Famciclovir
NDC 0093-8117

Generic Name
Famciclovir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-8118

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

Famciclovir
NDC 0093-8118

Generic Name
Famciclovir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-8119

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

Famciclovir
NDC 0093-8119

Generic Name
Famciclovir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-8192

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

Cimetidine
NDC 0093-8192

Generic Name
Cimetidine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-8204

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

Cimetidine
NDC 0093-8204

Generic Name
Cimetidine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-8305

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

Cimetidine
NDC 0093-8305

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

Diflunisal
NDC 0093-9222

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

Viatris Specialty LLC

NDC Product
Human Prescription Drug

Urelle
NDC 0037-6321

Generic Name
Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Sal...
Dosage Form
Tablet
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

NDC Product
Human Prescription Drug

Pristiq Extended-release
NDC 0008-1210

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

Pristiq Extended-release
NDC 0008-1211

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

Pristiq Extended-release
NDC 0008-1222

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

sanofi-aventis U.S. LLC

NDC Product
Human Prescription Drug

Priftin
NDC 0088-2102

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

Arava
NDC 0088-2160

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

Arava
NDC 0088-2161

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

Arava
NDC 0088-2162

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

External Clinical & Regulatory Resources

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