TALC
UNII 7SEV7J4R1U

Substance Identification & Data

This profile provides standardized clinical and technical data for Talc, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 7SEV7J4R1U.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 14807-96-6 and the RxNorm Concept ID (RxCUI) 10323. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
7SEV7J4R1U
CAS Registry Number
14807-96-6
RxNorm Concept ID
10323

Detailed Substance Profile

Preferred Name
TALC
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
7SEV7J4R1U
The specific atomic composition represented as a molecular structure string.
InChIKey
3Mg.O10Si4.2HO
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
QLQXSZZVUVMFHZ-UHFFFAOYSA-L
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C854
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
122173976
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
[Si]12(O[Si]3(O[Si]([O-])(O[Si]([O-])(O3)O1)O2)[O-])[O-].[Mg+2].[OH-].[Mg+2].[Mg+2].[OH-]

Synonyms and Nomenclature

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

TALC

Common Names & Synonyms

HUASHIFEN
PULVIS TALCI
PULVIS TALCI [CHP]
PURIFIED TALC [MART.]
TALC [EP IMPURITY]
TALC [EP MONOGRAPH]
TALC [FCC]
TALC [HSDB]
TALC [II]
TALC [JAN]
TALC [MI]
TALC [ORANGE BOOK]
TALC [USP MONOGRAPH]
TALC [VANDF]
TALC [WHO-DD]
TALC [WHO-IP]
TALC POWDER
TALCUM [WHO-IP LATIN]
TALCUM POWDER
TALCUM POWDER [II]

Brand / Trade Names

SCLEROSOL
STERITALC

Technical Codes

E-553(III)
INS NO.553(III)
INS-553(III)

NDC Products Containing TALC

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. 24
→ E.R. Squibb & Sons, L.L.C. 3
→ Eli Lilly and Company 18
→ Genentech, Inc. 7
→ Haleon US Holdings LLC 9
→ Hikma Pharmaceuticals USA Inc 4
→ Hikma Pharmaceuticals USA Inc. 18
→ Merck Sharp & Dohme LLC 17
→ Novartis Pharmaceuticals Corporation 40
→ Parke-Davis Div of Pfizer Inc 1
→ Pfizer Laboratories Div Pfizer Inc 21
→ Pharmacia & Upjohn Company LLC 3
→ Sanofi-Aventis U.S. LLC 1
→ Teva Pharmaceuticals USA, Inc. 26
→ Viatris Specialty LLC 1
→ Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 4
→ sanofi-aventis U.S. LLC 3

AbbVie Inc.

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

Kaletra
NDC 0074-0522

Generic Name
Lopinavir And Ritonavir
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

Norvir
NDC 0074-3399

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

Synthroid
NDC 0074-3727

Generic Name
Levothyroxine Sodium
Dosage Form
Tablet
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

Synthroid
NDC 0074-4341

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

Synthroid
NDC 0074-4552

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

Synthroid
NDC 0074-5182

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

Synthroid
NDC 0074-6594

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

Synthroid
NDC 0074-6624

Generic Name
Levothyroxine Sodium
Dosage Form
Tablet
Route
Oral
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
NDC Product
Human Prescription Drug

Synthroid
NDC 0074-7068

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

Synthroid
NDC 0074-7069

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

Synthroid
NDC 0074-7070

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

Synthroid
NDC 0074-7148

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

Synthroid
NDC 0074-7149

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

Synthroid
NDC 0074-9296

Generic Name
Levothyroxine Sodium
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing

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

NDC Product
Human Prescription Drug

Cobenfy
NDC 0003-0050

Generic Name
Xanomeline And Trospium Chloride
Dosage Form
Capsule, Coated Pellets
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Cobenfy
NDC 0003-0125

Generic Name
Xanomeline And Trospium Chloride
Dosage Form
Capsule, Coated Pellets
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

Inluriyo
NDC 0002-1717

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

Foundayo
NDC 0002-4178

Generic Name
Orforglipron
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

Foundayo
NDC 0002-4503

Generic Name
Orforglipron
Dosage Form
Tablet, Film Coated
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

Foundayo
NDC 0002-4794

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

Foundayo
NDC 0002-4803

Generic Name
Orforglipron
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

Foundayo
NDC 0002-4839

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

Foundayo
NDC 0002-4953

Generic Name
Orforglipron
Dosage Form
Tablet, Film Coated
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

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

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

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

Hikma Pharmaceuticals USA Inc

NDC Product
Human Prescription Drug

Imipramine Pamoate
NDC 0054-0273

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

Imipramine Pamoate
NDC 0054-0274

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

Imipramine Pamoate
NDC 0054-0275

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

Imipramine Pamoate
NDC 0054-0276

Generic Name
Imipramine Pamoate
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Desvenlafaxine
NDC 0054-0400

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

Desvenlafaxine
NDC 0054-0401

Generic Name
Desvenlafaxine
Dosage Form
Tablet, Film Coated, Extended Release
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

Desvenlafaxine
NDC 0054-0603

Generic Name
Desvenlafaxine
Dosage Form
Tablet, Film Coated, 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

Lithium Carbonate
NDC 0054-2526

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

Lithium Carbonate
NDC 0054-2527

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

Lithium Carbonate
NDC 0054-2531

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

Lithium Carbonate
NDC 0054-8526

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

Lithium Carbonate
NDC 0054-8527

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

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

Isentress
NDC 0006-0227

Generic Name
Raltegravir
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

Isentress
NDC 0006-0473

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

Isentress
NDC 0006-0477

Generic Name
Raltegravir
Dosage Form
Tablet, Chewable
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

Isentress
NDC 0006-3080

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

Isentress
NDC 0006-3603

Generic Name
Raltegravir
Dosage Form
Granule, For Suspension
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

Welireg
NDC 0006-5331

Generic Name
Belzutifan
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

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

Gleevec
NDC 0078-0401

Generic Name
Imatinib Mesylate
Dosage Form
Tablet
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

Exforge Hct
NDC 0078-0559

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

Exforge Hct
NDC 0078-0560

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

Exforge Hct
NDC 0078-0561

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

Exforge Hct
NDC 0078-0562

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

Exforge Hct
NDC 0078-0563

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

Gleevec
NDC 0078-0649

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

Entresto
NDC 0078-0659

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

Entresto
NDC 0078-0696

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

Piqray
NDC 0078-0701

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

Piqray
NDC 0078-0708

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

Tabrecta
NDC 0078-0709

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

Piqray
NDC 0078-0715

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

Tabrecta
NDC 0078-0716

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

Entresto
NDC 0078-0777

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

Kisqali
NDC 0078-0860

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

Kisqali
NDC 0078-0867

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

Kisqali
NDC 0078-0874

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

Mayzent
NDC 0078-0979

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

Mayzent
NDC 0078-0986

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

Vijoice
NDC 0078-1021

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

Vijoice
NDC 0078-1028

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

Vijoice
NDC 0078-1035

Generic Name
Alpelisib
Dosage Form
Kit
Route
N/A
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

Parke-Davis Div of Pfizer Inc

NDC Product
Human Prescription Drug

Dilantin Infatabs
NDC 0071-0007

Generic Name
Phenytoin
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
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

Lomotil
NDC 0025-0061

Generic Name
Diphenoxylate Hydrochloride And Atropine Sulfate
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Arthrotec
NDC 0025-1411

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

Arthrotec
NDC 0025-1421

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

Norpace Cr
NDC 0025-2732

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

Norpace Cr
NDC 0025-2742

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

Norpace
NDC 0025-2752

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

Norpace
NDC 0025-2762

Generic Name
Disopyramide Phosphate
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
NDA
Active Listing
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

Bosulif
NDC 0069-0193

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

Vizimpro
NDC 0069-0197

Generic Name
Dacomitinib
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

Velsipity
NDC 0069-0274

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

Vizimpro
NDC 0069-1198

Generic Name
Dacomitinib
Dosage Form
Tablet, Film Coated
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

Vizimpro
NDC 0069-2299

Generic Name
Dacomitinib
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

Pharmacia & Upjohn Company LLC

NDC Product
Human Prescription Drug

Cleocin Hydrochloride
NDC 0009-0225

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

Cleocin Hydrochloride
NDC 0009-0331

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

Cleocin Hydrochloride
NDC 0009-0395

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

Sanofi-Aventis U.S. LLC

NDC Product
Human Prescription Drug

Primaquine Phosphate
NDC 0024-1596

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

Teva Pharmaceuticals USA, Inc.

NDC Product
Drug For Further Processing

NDC 0093-0983

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

Nystatin
NDC 0093-0983

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

Amoxicillin
NDC 0093-2267

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

Amoxicillin
NDC 0093-2268

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

Lansoprazole
NDC 0093-3008

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

Lansoprazole
NDC 0093-3009

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

Rasagiline
NDC 0093-3060

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

Rasagiline
NDC 0093-3061

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

Amoxicillin
NDC 0093-3107

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

Amoxicillin
NDC 0093-3109

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

Amoxicillin
NDC 0093-4155

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

Dexmethylphenidate Hydrochloride
NDC 0093-5045

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

Dexmethylphenidate Hydrochloride
NDC 0093-5046

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

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

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

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

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

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

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

CAS
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NLM
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NLM
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