CROSCARMELLOSE SODIUM
UNII M28OL1HH48

Substance Identification & Data

This profile provides standardized clinical and technical data for Croscarmellose Sodium, uniquely identified by the FDA Unique Ingredient Identifier (UNII) M28OL1HH48.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 74811-65-7 and the RxNorm Concept ID (RxCUI) 1310573. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
M28OL1HH48
CAS Registry Number
74811-65-7
RxNorm Concept ID
1310573

Detailed Substance Profile

Preferred Name
CROSCARMELLOSE SODIUM
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
M28OL1HH48
The specific atomic composition represented as a molecular structure string.
NCI Thesaurus
C80923
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
6328154
Unique identification number in the NCBI database of chemical substances.
Substance Type
polymer
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

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

CROSCARMELLOSE SODIUM

Common Names & Synonyms

CROSCARMELLOSE SODIUM [EP IMPURITY]
CROSCARMELLOSE SODIUM [EP MONOGRAPH]
CROSCARMELLOSE SODIUM [II]
CROSCARMELLOSE SODIUM [JAN]
CROSCARMELLOSE SODIUM [MART.]
CROSCARMELLOSE SODIUM [MI]
CROSCARMELLOSE SODIUM [USAN]
CROSCARMELLOSE SODIUM [USP-RS]
CROSCARMELLOSE SODIUM [VANDF]
CROSCARMELLOSE SODIUM [WHO-DD]
CROSCARMELLOSE-SODIUM
CROSS-LINKED CARBOXYMETHYLCELLULOSE SODIUM
CROSS-LINKED CELLULOSE GUM
CROSS-LINKED CMC
CROSS-LINKED SODIUM CMC
E-468
INS NO.468
INS-468
MODIFIED CELLULOSE GUM
SODIUM CROSCARMELLOSE

Brand / Trade Names

AC-DI-SOL
PRIMELLOSE

NDC Products Containing CROSCARMELLOSE SODIUM

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. 5
→ Allergan, Inc. 2
→ E.R. Squibb & Sons, L.L.C. 12
→ Eli Lilly and Company 15
→ Genentech, Inc. 7
→ Haleon US Holdings LLC 3
→ Hikma Pharmaceuticals USA Inc 3
→ Hikma Pharmaceuticals USA Inc. 21
→ Hikma Pharmacuticals USA USA Inc. 1
→ L. Perrigo Company 3
→ Merck Sharp & Dohme LLC 27
→ Novartis Pharmaceuticals Corporation 4
→ PFIZER LABORATORIES DIV PFIZER INC 1
→ Parke-Davis Div of Pfizer Inc 1
→ Pfizer Laboratories Div Pfizer Inc 27
→ Roerig 2
→ Sanofi-Aventis U.S. LLC 5
→ Teva Pharmaceuticals USA, Inc. 59
→ Viatris Specialty LLC 2

AbbVie Inc.

NDC Product
Human Prescription Drug

Mavyret
NDC 0074-2600

Generic Name
Glecaprevir And Pibrentasvir
Dosage Form
Pellet
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Mavyret
NDC 0074-2625

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

Qulipta
NDC 0074-7094

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

Qulipta
NDC 0074-7095

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

Qulipta
NDC 0074-7096

Generic Name
Atogepant
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing

Allergan, Inc.

NDC Product
Human Prescription Drug

Ubrelvy
NDC 0023-6498

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

Ubrelvy
NDC 0023-6501

Generic Name
Ubrogepant
Dosage Form
Tablet
Route
Oral
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

Eliquis
NDC 0003-0893

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

Eliquis
NDC 0003-0894

Generic Name
Apixaban
Dosage Form
Tablet, Film Coated
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
NDC Product
Human Prescription Drug

Evotaz
NDC 0003-3641

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

Eliquis 30-day Starter Pack
NDC 0003-3764

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

Augtyro
NDC 0003-4040

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

Eli Lilly and Company

NDC Product
Human Prescription Drug

Inluriyo
NDC 0002-1717

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

Reyvow
NDC 0002-4312

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

Cialis
NDC 0002-4462

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

Cialis
NDC 0002-4463

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

Cialis
NDC 0002-4464

Generic Name
Tadalafil
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

Reyvow
NDC 0002-4491

Generic Name
Lasmiditan
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
NDC Product
Human Prescription Drug

Baricitinib
NDC 0002-6885

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

Jaypirca
NDC 0002-6902

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

Jaypirca
NDC 0002-7026

Generic Name
Pirtobrutinib
Dosage Form
Tablet, Coated
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

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

Febuxostat
NDC 0054-0413

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

Febuxostat
NDC 0054-0414

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

Pyrazinamide
NDC 0054-0812

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

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Flecainide Acetate
NDC 0054-0010

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

Flecainide Acetate
NDC 0054-0011

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

Flecainide Acetate
NDC 0054-0012

Generic Name
Flecainide Acetate
Dosage Form
Tablet
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

Irbesartan And Hydrochlorothiazide
NDC 0054-0254

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

Irbesartan And Hydrochlorothiazide
NDC 0054-0255

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

Naratriptan
NDC 0054-0278

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

Naratriptan
NDC 0054-0279

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

Rufinamide
NDC 0054-0425

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

Rufinamide
NDC 0054-0426

Generic Name
Rufinamide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
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

Fluticasone Propionate
NDC 0054-3270

Generic Name
Fluticasone Propionate
Dosage Form
Spray, Metered
Route
Nasal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Meperidine Hydrochloride
NDC 0054-3545

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

Leucovorin Calcium
NDC 0054-4496

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

Leucovorin Calcium
NDC 0054-4497

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

Leucovorin Calcium
NDC 0054-4498

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

Leucovorin Calcium
NDC 0054-4499

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

Leucovorin Calcium
NDC 0054-8496

Generic Name
Leucovorin Calcium
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Hikma Pharmacuticals USA USA Inc.

NDC Product
Human Prescription Drug

Clotrimazole
NDC 0054-4146

Generic Name
Clotrimazole
Dosage Form
Lozenge
Route
Oral; Topical
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 Anti Diarrheal Anti Gas
NDC 0113-0087

Generic Name
Loperamide Hydrochloride, Simethicone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Merck Sharp & Dohme LLC

NDC Product
Human Prescription Drug

Belsomra
NDC 0006-0005

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

Belsomra
NDC 0006-0033

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

Belsomra
NDC 0006-0325

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

Belsomra
NDC 0006-0335

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

Zolinza
NDC 0006-0568

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

Pifeltro
NDC 0006-3069

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

Zepatier
NDC 0006-3074

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

Prevymis
NDC 0006-3075

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

Prevymis
NDC 0006-3076

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

Isentress
NDC 0006-3080

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

Prevymis
NDC 0006-5003

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

Prevymis
NDC 0006-5004

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

Delstrigo
NDC 0006-5007

Generic Name
Doravirine, Lamivudine, And Tenofovir Disoproxil Fumarate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Verquvo
NDC 0006-5028

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

Verquvo
NDC 0006-5029

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

Verquvo
NDC 0006-5030

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

Lagevrio
NDC 0006-5055

Generic Name
Molnupiravir
Dosage Form
Capsule
Route
Oral
Marketing
EMERGENCY USE AUTHORIZATION
Active Listing
NDC Product
Human Prescription Drug

Idvynso
NDC 0006-5092

Generic Name
Doravirine, Islatravir
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
NDC Product
Human Prescription Drug

Steglujan
NDC 0006-5367

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

Steglujan
NDC 0006-5368

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

Noxafil
NDC 0085-2224

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

Noxafil
NDC 0085-4324

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

Noxafil
NDC 0085-4331

Generic Name
Posaconazole
Dosage Form
Solution
Route
Intravenous
Marketing
NDA
Active Listing

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Coartem
NDC 0078-0568

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

Scemblix
NDC 0078-1091

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

Scemblix
NDC 0078-1098

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

Rhapsido
NDC 0078-1483

Generic Name
Remibrutinib
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing

PFIZER LABORATORIES DIV PFIZER INC

NDC Product
Human Prescription Drug

Revatio
NDC 0069-4190

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

Parke-Davis Div of Pfizer Inc

NDC Product
Human Prescription Drug

Nardil
NDC 0071-0350

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

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Bosulif
NDC 0069-0135

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

Bosulif
NDC 0069-0136

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

Inlyta
NDC 0069-0145

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

Inlyta
NDC 0069-0151

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

Bosulif
NDC 0069-0193

Generic Name
Bosutinib
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

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 0069-1001

Generic Name
Tofacitinib
Dosage Form
Tablet, Film Coated
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

Caduet
NDC 0069-2260

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

Zithromax
NDC 0069-3060

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

Zithromax
NDC 0069-3070

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

Zithromax
NDC 0069-3120

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

Zithromax
NDC 0069-3130

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

Zithromax
NDC 0069-3140

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

Zithromax
NDC 0069-4061

Generic Name
Azithromycin Dihydrate
Dosage Form
Tablet, Film Coated
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

Roerig

NDC Product
Human Prescription Drug

Vfend
NDC 0049-3160

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

Diflucan
NDC 0049-3450

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

Sanofi-Aventis U.S. LLC

NDC Product
Human Prescription Drug

Fexinidazole
NDC 0024-4512

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

Avapro
NDC 0024-5851

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

Avapro
NDC 0024-5852

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

Tolterodine Tartrate
NDC 0093-0010

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

Tolterodine Tartrate
NDC 0093-0018

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

Warfarin Sodium
NDC 0093-1712

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

Warfarin Sodium
NDC 0093-1713

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

Warfarin Sodium
NDC 0093-1714

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

Warfarin Sodium
NDC 0093-1715

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

Warfarin Sodium
NDC 0093-1716

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

Warfarin Sodium
NDC 0093-1718

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

Warfarin Sodium
NDC 0093-1720

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

Warfarin Sodium
NDC 0093-1721

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

Tri-lo-sprintec
NDC 0093-2140

Generic Name
Norgestimate And Ethinyl Estradiol
Dosage Form
Kit
Route
N/A
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

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

Cefadroxil
NDC 0093-4059

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

Atorvastatin Calcium
NDC 0093-5056

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

Atorvastatin Calcium
NDC 0093-5057

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

Atorvastatin Calcium
NDC 0093-5058

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

Atorvastatin Calcium
NDC 0093-5059

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

Almotriptan Malate
NDC 0093-5260

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

Almotriptan Malate
NDC 0093-5261

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

Sildenafil
NDC 0093-5341

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

Sildenafil
NDC 0093-5342

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

Sildenafil
NDC 0093-5343

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

Erythromycin
NDC 0093-5571

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

NDC 0093-5571

Generic Name
Erythromycin
Dosage Form
Tablet, Film Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-5572

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

Erythromycin
NDC 0093-5572

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

NDC 0093-5938

Generic Name
Lanthanum Carbonate
Dosage Form
Tablet, Chewable
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Lanthanum Carbonate
NDC 0093-5938

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

Lanthanum Carbonate
NDC 0093-5939

Generic Name
Lanthanum Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-5939

Generic Name
Lanthanum Carbonate
Dosage Form
Tablet, Chewable
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-5940

Generic Name
Lanthanum Carbonate
Dosage Form
Tablet, Chewable
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Lanthanum Carbonate
NDC 0093-5940

Generic Name
Lanthanum Carbonate
Dosage Form
Tablet, Chewable
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

Glipizide And Metformin Hydrochloride
NDC 0093-7455

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

Glipizide And Metformin Hydrochloride
NDC 0093-7456

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

Glipizide And Metformin Hydrochloride
NDC 0093-7457

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

Capecitabine
NDC 0093-7473

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

Capecitabine
NDC 0093-7474

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

Imatinib Mesylate
NDC 0093-7629

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

Imatinib Mesylate
NDC 0093-7630

Generic Name
Imatinib Mesylate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
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
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

Irbesartan And Hydrochlorothiazide
NDC 0093-8232

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

Irbesartan And Hydrochlorothiazide
NDC 0093-8238

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

Eletriptan Hydrobromide
NDC 0093-8310

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

Eletriptan Hydrobromide
NDC 0093-8311

Generic Name
Eletriptan Hydrobromide
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

Edluar
NDC 0037-6010

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

Edluar
NDC 0037-6050

Generic Name
Zolpidem Tartrate
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing

External Clinical & Regulatory Resources

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