MANNITOL
UNII 3OWL53L36A

Substance Identification & Data

This profile provides standardized clinical and technical data for Mannitol, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 3OWL53L36A.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 69-65-8 and the RxNorm Concept ID (RxCUI) 6628. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
3OWL53L36A
CAS Registry Number
69-65-8
RxNorm Concept ID
6628

Detailed Substance Profile

Preferred Name
MANNITOL
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
3OWL53L36A
The specific atomic composition represented as a molecular structure string.
InChIKey
C6H14O6
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
FBPFZTCFMRRESA-KVTDHHQDSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C625
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
6251
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
[C@H]([C@@H]([C@H](O)CO)O)([C@H](O)CO)O

Synonyms and Nomenclature

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

MANNITOL

Common Names & Synonyms

CORDYCEPIC ACID
CRYSTALLINE MANNITOL EXTRA-FINE
CRYSTALLINE MANNITOL FINE
CRYSTALLINE MANNITOL STANDARD
D-(-)-MANNITOL
D-MANNITOL
D-MANNITOL [JAN]
D-MANNITOL [WHO-IP]
ISOMALT IMPURITY B [EP IMPURITY]
ISOMALT IMPURITY, MANNITOL- [USP IMPURITY]
LACTITOL MONOHYDRATE IMPURITY C [EP IMPURITY]
MANNITE
MANNITOL [EP IMPURITY]
MANNITOL [EP MONOGRAPH]
MANNITOL [FCC]
MANNITOL [HSDB]
MANNITOL [II]
MANNITOL [MART.]
MANNITOL [MI]
MANNITOL [ORANGE BOOK]
MANNITOL [USP MONOGRAPH]
MANNITOL [USP-RS]
MANNITOL [VANDF]
MANNITOL [WHO-DD]
MANNITOL 200
MANNITOL 2080
MANNITOL 2080 [II]
MANNITOL 25
MANNITOL 300
MANNITOL 35
MANNITOL 60
MANNITOL 60 [II]
MANNITOL M300
MANNITOL M300 [II]
MANNITOL, D-
MANNITOLUM [WHO-IP LATIN]
SORBITOL-MANNITOL COMPONENT MANNITOL

Brand / Trade Names

BRONCHITOL
MANNOGEM 2080
OSMITROL
PEARLITOL 160 C
PEARLITOL 200 SD
PEARLITOL 25 C
PEARLITOL 300 DC
PEARLITOL 50 C
RESECTISOL

Technical Codes

E-421
INS NO.421
INS-421
NSC-407017

NDC Products Containing MANNITOL

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. 25
→ Alcon Laboratories, Inc. 2
→ Allergan, Inc. 2
→ CSL Behring LLC 1
→ E.R. Squibb & Sons, L.L.C. 5
→ Eli Lilly and Company 12
→ Haleon US Holdings LLC 7
→ Hikma Pharmaceuticals USA Inc 2
→ Hikma Pharmaceuticals USA Inc. 10
→ L Perrigo Company 1
→ L. Perrigo Company 26
→ Merck Sharp & Dohme LLC 9
→ Novartis Pharmaceuticals Corporation 33
→ Parke-Davis Div of Pfizer Inc 1
→ Pfizer Laboratories Div Pfizer Inc 17
→ Pharmacia & Upjohn Company LLC 7
→ Roerig 3
→ Sanofi-Aventis U.S. LLC 4
→ Teva Pharmaceuticals USA, Inc. 28
→ Viatris Specialty LLC 2
→ Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 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

Humira
NDC 0074-0124

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

Humira
NDC 0074-0243

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

Humira
NDC 0074-0554

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

Humira
NDC 0074-0616

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

Humira
NDC 0074-0817

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

Humira
NDC 0074-1539

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

Lupron Depot-ped
NDC 0074-2108

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

Lupron Depot-ped
NDC 0074-2282

Generic Name
Leuprolide Acetate
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

Lupron Depot-ped
NDC 0074-2440

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

Humira
NDC 0074-2540

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

Lupron Depot
NDC 0074-3346

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

Lupron Depot
NDC 0074-3473

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

Lupron Depot
NDC 0074-3641

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

Lupron Depot
NDC 0074-3642

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

Lupron Depot
NDC 0074-3683

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

Lupron Depot-ped
NDC 0074-3779

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

Humira
NDC 0074-3799

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

Humira
NDC 0074-4339

Generic Name
Adalimumab
Dosage Form
Kit
Route
N/A
Marketing
BLA
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
NDC Product
Human Prescription Drug

Lupron Depot-ped
NDC 0074-9694

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

Alcon Laboratories, Inc.

NDC Product
Human Otc Drug

Pataday Once Daily Relief
NDC 0065-0816

Generic Name
Olopatadine Hydrochloride
Dosage Form
Solution
Route
Ophthalmic
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Simbrinza
NDC 0065-4147

Generic Name
Brinzolamide/brimonidine Tartrate
Dosage Form
Suspension/ Drops
Route
Ophthalmic
Marketing
NDA
Active Listing

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

CSL Behring LLC

NDC Product
Plasma Derivative

Zemaira
NDC 0053-7201

Generic Name
Alpha-1-proteinase Inhibitor Human
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing

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

NDC Product
Human Prescription Drug

Yervoy
NDC 0003-2327

Generic Name
Ipilimumab
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Yervoy
NDC 0003-2328

Generic Name
Ipilimumab
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Opdivo
NDC 0003-3734

Generic Name
Nivolumab
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Opdivo
NDC 0003-3772

Generic Name
Nivolumab
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Opdivo
NDC 0003-3774

Generic Name
Nivolumab
Dosage Form
Injection
Route
Intravenous
Marketing
BLA
Active Listing

Eli Lilly and Company

NDC Product
Human Prescription Drug

Trulicity
NDC 0002-1433

Generic Name
Dulaglutide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Trulicity
NDC 0002-1434

Generic Name
Dulaglutide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Trulicity
NDC 0002-2236

Generic Name
Dulaglutide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Trulicity
NDC 0002-3182

Generic Name
Dulaglutide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
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

Olumiant
NDC 0002-4732

Generic Name
Baricitinib
Dosage Form
Tablet, Film Coated
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

Alimta
NDC 0002-7623

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

Alimta
NDC 0002-7640

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

Humatrope
NDC 0002-8147

Generic Name
Somatropin
Dosage Form
Kit
Route
Intramuscular; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humatrope
NDC 0002-8148

Generic Name
Somatropin
Dosage Form
Kit
Route
Intramuscular; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humatrope
NDC 0002-8149

Generic Name
Somatropin
Dosage Form
Kit
Route
Intramuscular; Subcutaneous
Marketing
BLA
Active Listing

Haleon US Holdings LLC

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 Direct Cough
NDC 0031-9302

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

Robitussin Long-acting Cough Soft Chews
NDC 0031-9310

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

Robitussin Nighttime Cough Dm Soft Chews
NDC 0031-9311

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

Theraflu Severe Cold Relief Soft Chews
NDC 0067-0111

Generic Name
Acetaminophen, Dextromethorphan Hbr
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hikma Pharmaceuticals USA Inc

NDC Product
Human Prescription Drug

Prucalopride
NDC 0054-0749

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

Prucalopride
NDC 0054-0750

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

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Buprenorphine
NDC 0054-0176

Generic Name
Buprenorphine
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine
NDC 0054-0177

Generic Name
Buprenorphine
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Linezolid
NDC 0054-0319

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

Sapropterin Dihydrochloride
NDC 0054-0906

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

Eltrombopag
NDC 0054-0962

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

Eltrombopag
NDC 0054-0963

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

Eltrombopag
NDC 0054-0964

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

Eltrombopag
NDC 0054-0965

Generic Name
Eltrombopag Olamine
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

L Perrigo Company

NDC Product
Human Otc Drug

Mederma Pm
NDC 0113-4124

Generic Name
Dimethicone
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

L. Perrigo Company

NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0053

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Lansoprazole
NDC 0113-0116

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

Good Sense Nicotine
NDC 0113-0344

Generic Name
Nicotine Polacrilex
Dosage Form
Lozenge
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0456

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Omeprazole
NDC 0113-0520

Generic Name
Omeprazole
Dosage Form
Tablet, Orally Disintegrating, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0532

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0734

Generic Name
Nicotine Polacrilex
Dosage Form
Lozenge
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0854

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0873

Generic Name
Nicotine Polacrilex
Dosage Form
Lozenge
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0957

Generic Name
Nicotine Polacrilex
Dosage Form
Lozenge
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense All Day Allergy
NDC 0113-0981

Generic Name
Cetirizine Hydrochloride
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
ANDA
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 Nicotine
NDC 0113-1125

Generic Name
Nicotine Polacrilex
Dosage Form
Lozenge
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-1190

Generic Name
Nicotine Polacrilex
Dosage Form
Lozenge
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Allergy Relief
NDC 0113-1191

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-1352

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Childrens Ibuprofen
NDC 0113-2461

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

Good Sense Nicotine
NDC 0113-2502

Generic Name
Nicotine Polacrilex
Dosage Form
Lozenge
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-5023

Generic Name
Nicotine Polacrilex
Dosage Form
Lozenge
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-6020

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Childrens Ibuprofen
NDC 0113-6040

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

Prevacid 24 Hr
NDC 0113-6117

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

Good Sense Nicotine
NDC 0113-7020

Generic Name
Nicotine Polacrilex
Dosage Form
Lozenge
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-7031

Generic Name
Nicotine Polacrilex
Dosage Form
Lozenge
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Childrens Ibuprofen
NDC 0113-7366

Generic Name
Ibuprofen
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing

Merck Sharp & Dohme LLC

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

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

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

Cancidas
NDC 0006-3822

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

Cancidas
NDC 0006-3823

Generic Name
Caspofungin Acetate
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
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

Temodar
NDC 0085-1381

Generic Name
Temozolomide
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
NDA
Active Listing

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Sandostatin
NDC 0078-0180

Generic Name
Octreotide Acetate
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Sandostatin
NDC 0078-0181

Generic Name
Octreotide Acetate
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Sandostatin
NDC 0078-0182

Generic Name
Octreotide Acetate
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Simulect
NDC 0078-0331

Generic Name
Basiliximab
Dosage Form
Injection, Powder, For Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Simulect
NDC 0078-0393

Generic Name
Basiliximab
Dosage Form
Injection, Powder, For Solution
Route
Intravenous
Marketing
BLA
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

Gilenya
NDC 0078-0607

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

Afinitor Disperz
NDC 0078-0626

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

Afinitor Disperz
NDC 0078-0627

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

Afinitor Disperz
NDC 0078-0628

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

Hycamtin
NDC 0078-0674

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

Promacta
NDC 0078-0684

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

Promacta
NDC 0078-0685

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

Promacta
NDC 0078-0686

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

Promacta
NDC 0078-0687

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

Promacta
NDC 0078-0697

Generic Name
Eltrombopag Olamine
Dosage Form
Powder, For Suspension
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

Ilaris
NDC 0078-0734

Generic Name
Canakinumab
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Sandostatin Lar Depot
NDC 0078-0811

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

Sandostatin Lar Depot
NDC 0078-0818

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

Sandostatin Lar Depot
NDC 0078-0825

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

Gilenya
NDC 0078-0965

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

Promacta
NDC 0078-0972

Generic Name
Eltrombopag Olamine
Dosage Form
Powder, For Suspension
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

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

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

Genotropin
NDC 0013-2626

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

Genotropin
NDC 0013-2646

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

Genotropin
NDC 0013-2649

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

Genotropin
NDC 0013-2650

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

Genotropin
NDC 0013-2651

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

Genotropin
NDC 0013-2652

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

Genotropin
NDC 0013-2653

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

Genotropin
NDC 0013-2654

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

Genotropin
NDC 0013-2655

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

Genotropin
NDC 0013-2656

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

Genotropin
NDC 0013-2657

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

Genotropin
NDC 0013-2658

Generic Name
Somatropin
Dosage Form
Kit
Route
N/A
Marketing
BLA
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

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

Pharmacia & Upjohn Company LLC

NDC Product
Human Prescription Drug

Zyvox
NDC 0009-5136

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

Somavert
NDC 0009-7166

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

Somavert
NDC 0009-7168

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

Somavert
NDC 0009-7188

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

Somavert
NDC 0009-7199

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

Somavert
NDC 0009-7200

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

Aromasin
NDC 0009-7663

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

Roerig

NDC Product
Human Prescription Drug

Eraxis
NDC 0049-0114

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

Eraxis
NDC 0049-0116

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

Eraxis
NDC 0049-2242

Generic Name
Anidulafungin
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
NDA
Active Listing

Sanofi-Aventis U.S. LLC

NDC Product
Human Prescription Drug

Plavix
NDC 0024-1171

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

Plavix
NDC 0024-1332

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

Elitek
NDC 0024-5150

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

Elitek
NDC 0024-5151

Generic Name
Rasburicase
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Cefaclor
NDC 0093-1087

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

Teriparatide
NDC 0093-1106

Generic Name
Teriparatide
Dosage Form
Injection, Solution
Route
Subcutaneous
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

Amoxicillin And Clavulanate Potassium
NDC 0093-2277

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

Amoxicillin And Clavulanate Potassium
NDC 0093-2279

Generic Name
Amoxicillin And Clavulanate Potassium
Dosage Form
Powder, For Suspension
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

Olanzapine
NDC 0093-5245

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

Olanzapine
NDC 0093-5246

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

Olanzapine
NDC 0093-5247

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

Olanzapine
NDC 0093-5248

Generic Name
Olanzapine
Dosage Form
Tablet, Orally Disintegrating
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

Clozapine
NDC 0093-5416

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

Clozapine
NDC 0093-5417

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

Clozapine
NDC 0093-5419

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

Pioglitazone
NDC 0093-7271

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

Pioglitazone
NDC 0093-7272

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

Pioglitazone
NDC 0093-7273

Generic Name
Pioglitazone
Dosage Form
Tablet
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

Finzala
NDC 0093-8210

Generic Name
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fuma...
Dosage Form
Kit
Route
N/A
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

Amoxicillin And Clavulanate Potassium
NDC 0093-8675

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

Clonazepam
NDC 0093-9293

Generic Name
Clonazepam
Dosage Form
Tablet, Orally Disintegrating
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

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

NDC Product
Human Prescription Drug

Protonix Delayed-release
NDC 0008-0841

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

Protonix Delayed-release
NDC 0008-0843

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

Protonix Delayed-release
NDC 0008-0844

Generic Name
Pantoprazole Sodium
Dosage Form
Granule, Delayed Release
Route
Oral
Marketing
NDA
Active Listing

External Clinical & Regulatory Resources

CAS
Common Chemistry
NCATS
Inxight Drugs
NLM
DailyMed Products
NCATS
GSRS Full Record
NIH
NCI Thesaurus
NLM
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