POLYSORBATE 80
UNII 6OZP39ZG8H

Substance Identification & Data

This profile provides standardized clinical and technical data for Polysorbate 80, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 6OZP39ZG8H.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 9005-65-6 and the RxNorm Concept ID (RxCUI) 8560. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
6OZP39ZG8H
CAS Registry Number
9005-65-6
RxNorm Concept ID
8560

Detailed Substance Profile

Preferred Name
POLYSORBATE 80
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
6OZP39ZG8H
The specific atomic composition represented as a molecular structure string.
NCI Thesaurus
C80656
National Cancer Institute reference terminology for clinical and research data.
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 Polysorbate 80. 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

PEG-20 SORBITAN OLEATE
POLYSORBATE 80

Common Names & Synonyms

MF59 COMPONENT TWEEN 80
POLYOXYETHYLENE 20 SORBITAN MONOOLEATE
POLYOXYETHYLENE 20 SORBITAN MONOOLEATE [WHO-IP]
POLYOXYETHYLENE(20)SORBITAN MONOOLEATE
POLYSORBATA 80 [WHO-IP LATIN]
POLYSORBATE 80 [EP MONOGRAPH]
POLYSORBATE 80 [FCC]
POLYSORBATE 80 [FHFI]
POLYSORBATE 80 [HSDB]
POLYSORBATE 80 [II]
POLYSORBATE 80 [JAN]
POLYSORBATE 80 [MART.]
POLYSORBATE 80 [MI]
POLYSORBATE 80 [USAN]
POLYSORBATE 80 [USP-RS]
POLYSORBATE 80 [VANDF]
POLYSORBATE 80 [WHO-DD]
POLYSORBATE 80 [WHO-IP]
SORBIMACROGOL OLEATE 300

Brand / Trade Names

SORBAX PMO-20
TWEEN 80
TWEEN-80

Technical Codes

E-433
FEMA NO. 2917
INS NO.433
INS-433

NDC Products Containing POLYSORBATE 80

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. 29
→ Alcon Laboratories, Inc. 1
→ Allergan, Inc. 8
→ Bayer HealthCare LLC 9
→ E.R. Squibb & Sons, L.L.C. 14
→ Eli Lilly and Company 18
→ Genentech, Inc. 2
→ Haleon US Holdings LLC 14
→ Hikma Pharmaceuticals USA Inc. 12
→ Merck Sharp & Dohme LLC 20
→ Novartis Pharmaceuticals Corporation 9
→ Parke-Davis Div of Pfizer Inc 1
→ Pfizer Laboratories Div Pfizer Inc 21
→ Pharmacia & Upjohn Company LLC 8
→ Roerig 3
→ Sanofi-Aventis U.S. LLC 5
→ Teva Pharmaceuticals USA, Inc. 18
→ Viatris Specialty LLC 1
→ Wyeth Pharmaceutical Division of Wyeth Holdings LLC 2
→ Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 5

AbbVie Inc.

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

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

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

Emrelis
NDC 0074-1044

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

Emrelis
NDC 0074-1055

Generic Name
Telisotuzumab Vedotin
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
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

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

Gengraf
NDC 0074-3108

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

Gengraf
NDC 0074-3109

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

Lupron Depot
NDC 0074-3346

Generic Name
Leuprolide Acetate
Dosage Form
Kit
Route
N/A
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

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

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

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

Genteal Tears (moderate)
NDC 0065-0426

Generic Name
Dextran 70, Glycerin, Hypromellose
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing

Allergan, Inc.

NDC Product
Human Otc Drug

Refresh Optive Mega-3 Pf
NDC 0023-3988

Generic Name
Carboxymethylcellulose Sodium, Glycerin, Polysorbate 80
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Refresh Optive Advanced
NDC 0023-4307

Generic Name
Carboxymethylcellulose Sodium, Glycerin, And Polysorbate 80
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Refresh Optive Advanced
NDC 0023-4491

Generic Name
Carboxymethylcellulose Sodium, Glycerin, Polysorbate 80
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Restasis Multidose
NDC 0023-5301

Generic Name
Cyclosporine
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Refresh Optive Mega-3
NDC 0023-5773

Generic Name
Carboxymethylcellulose Sodium, Glycerin And Polysorbate 80
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Refresh Digital
NDC 0023-6952

Generic Name
Carboxymethylcellulose Sodium, Glycerin, Polysorbate 80
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Refresh Digital Pf
NDC 0023-6954

Generic Name
Carboxymethylcellulose Sodium, Glycerin And Polysorbate 80
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Restasis
NDC 0023-9163

Generic Name
Cyclosporine
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
NDA
Active Listing

Bayer HealthCare LLC

NDC Product
Plasma Derivative

Kovaltry
NDC 0026-3821

Generic Name
Antihemophilic Factor (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Kovaltry
NDC 0026-3822

Generic Name
Antihemophilic Factor (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Kovaltry
NDC 0026-3824

Generic Name
Antihemophilic Factor (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Kovaltry
NDC 0026-3826

Generic Name
Antihemophilic Factor (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Kovaltry
NDC 0026-3828

Generic Name
Antihemophilic Factor (recombinant)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Jivi
NDC 0026-3942

Generic Name
Antihemophilic Factor (recombinant) Pegylated-aucl
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Jivi
NDC 0026-3944

Generic Name
Antihemophilic Factor (recombinant) Pegylated-aucl
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Jivi
NDC 0026-3946

Generic Name
Antihemophilic Factor (recombinant) Pegylated-aucl
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Jivi
NDC 0026-3948

Generic Name
Antihemophilic Factor (recombinant) Pegylated-aucl
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing

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

NDC Product
Human Prescription Drug

Kenalog-40
NDC 0003-0293

Generic Name
Triamcinolone Acetonide
Dosage Form
Injection, Suspension
Route
Intra-articular; Intramuscular
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Kenalog-10
NDC 0003-0494

Generic Name
Triamcinolone Acetonide
Dosage Form
Injection, Suspension
Route
Intra-articular; Intralesional
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Baraclude
NDC 0003-1611

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

Baraclude
NDC 0003-1612

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

Baraclude
NDC 0003-1614

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

Empliciti
NDC 0003-2291

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

Empliciti
NDC 0003-4522

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

Opdivo Qvantig
NDC 0003-6120

Generic Name
Nivolumab And Hyaluronidase-nvhy
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Opdualag
NDC 0003-7125

Generic Name
Nivolumab And Relatlimab-rmbw
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

Emgality
NDC 0002-1436

Generic Name
Galcanezumab-gnlm
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Drug For Further Processing

NDC 0002-1436

Generic Name
Galcanezumab-gnlm
Dosage Form
Injection, Solution
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Taltz
NDC 0002-1445

Generic Name
Ixekizumab
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

Emgality
NDC 0002-2377

Generic Name
Galcanezumab-gnlm
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Drug For Further Processing

NDC 0002-2377

Generic Name
Galcanezumab-gnlm
Dosage Form
Injection, Solution
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Drug For Further Processing

NDC 0002-3115

Generic Name
Galcanezumab-gnlm
Dosage Form
Injection, Solution
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Emgality
NDC 0002-3115

Generic Name
Galcanezumab-gnlm
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

Evista
NDC 0002-4184

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

Omvoh
NDC 0002-7575

Generic Name
Mirikizumab-mrkz
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Cyramza
NDC 0002-7669

Generic Name
Ramucirumab
Dosage Form
Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Cyramza
NDC 0002-7678

Generic Name
Ramucirumab
Dosage Form
Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Taltz
NDC 0002-7724

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

Omvoh
NDC 0002-8011

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

Kisunla
NDC 0002-9401

Generic Name
Donanemab-azbt
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing

Genentech, Inc.

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

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8655

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8753

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8754

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8755

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Excedrin Pm Triple Action Caplets
NDC 0067-2056

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

Excedrin Rapid Relief
NDC 0067-2200

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

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

Deferiprone
NDC 0054-0576

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

Deferiprone
NDC 0054-0711

Generic Name
Deferiprone
Dosage Form
Tablet, Coated
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
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

Prednisone Intensol
NDC 0054-3721

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

Prednisone
NDC 0054-3722

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

Prednisone
NDC 0054-8724

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

Prednisone
NDC 0054-8739

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

Prednisone
NDC 0054-8740

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

Merck Sharp & Dohme LLC

NDC Product
Human Prescription Drug

Zinplava
NDC 0006-3025

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

Keytruda
NDC 0006-3026

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

Emend
NDC 0006-3061

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

Keytruda Qlex
NDC 0006-3083

Generic Name
Pembrolizumab And Berahyaluronidase Alfa-pmph
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Vaccine

Gardasil
NDC 0006-4045

Generic Name
Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18) ...
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
BLA
Active Listing
NDC Product
Vaccine

Rotateq
NDC 0006-4047

Generic Name
Rotavirus Vaccine, Live, Oral, Pentavalent
Dosage Form
Solution
Route
Oral
Marketing
BLA
Active Listing
NDC Product
Vaccine

Gardasil
NDC 0006-4109

Generic Name
Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18) ...
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
BLA
Active Listing
NDC Product
Vaccine

Gardasil 9
NDC 0006-4119

Generic Name
Human Papillomavirus 9-valent Vaccine, Recombinant
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
BLA
Active Listing
NDC Product
Vaccine

Gardasil 9
NDC 0006-4121

Generic Name
Human Papillomavirus 9-valent Vaccine, Recombinant
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Enflonsia
NDC 0006-5073

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

Keytruda Qlex
NDC 0006-5083

Generic Name
Pembrolizumab And Berahyaluronidase Alfa-pmph
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Winrevair
NDC 0006-5087

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

Winrevair
NDC 0006-5088

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

Winrevair
NDC 0006-5090

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

Winrevair
NDC 0006-5091

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

Noxafil
NDC 0085-1328

Generic Name
Posaconazole
Dosage Form
Suspension
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
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

Cosentyx
NDC 0078-0639

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

Tykerb
NDC 0078-0671

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

Ilaris
NDC 0078-0734

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

Beovu
NDC 0078-0827

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

Adakveo
NDC 0078-0883

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

Triesence
NDC 0078-0897

Generic Name
Triamcinolone Acetonide
Dosage Form
Injection, Suspension
Route
Ophthalmic
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Kesimpta
NDC 0078-1007

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

Cosentyx
NDC 0078-1056

Generic Name
Secukinumab
Dosage Form
Injection
Route
Subcutaneous
Marketing
BLA
Active Listing

Parke-Davis Div of Pfizer Inc

NDC Product
Human Prescription Drug

Lopid
NDC 0071-0737

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

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Abrilada
NDC 0025-0325

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

Abrilada
NDC 0025-0328

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

Abrilada
NDC 0025-0333

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

Ruxience
NDC 0069-0238

Generic Name
Rituximab-pvvr
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Ruxience
NDC 0069-0249

Generic Name
Rituximab-pvvr
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Nivestym
NDC 0069-0291

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

Nivestym
NDC 0069-0292

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

Nivestym
NDC 0069-0293

Generic Name
Filgrastim-aafi
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Nivestym
NDC 0069-0294

Generic Name
Filgrastim-aafi
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Zirabev
NDC 0069-0315

Generic Name
Bevacizumab-bvzr
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Zirabev
NDC 0069-0342

Generic Name
Bevacizumab-bvzr
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Vaccine

Penbraya
NDC 0069-0600

Generic Name
Meningococcal Groups A, B, C, W, And Y Vaccine
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Inflectra
NDC 0069-0809

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

Hympavzi
NDC 0069-2151

Generic Name
Marstacimab-hncq
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
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

Elrexfio
NDC 0069-2522

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

Elrexfio
NDC 0069-4494

Generic Name
Elranatamab-bcmm
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
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
NDC Product
Human Prescription Drug

Vyndamax
NDC 0069-8730

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

Pharmacia & Upjohn Company LLC

NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-0274

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intralesional; Intramuscular; Intrasynovial; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-0280

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intralesional; Intramuscular; Intrasynovial; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-0306

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intralesional; Intramuscular; Intrasynovial; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-provera
NDC 0009-0746

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-subq Provera
NDC 0009-4709

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Nicotrol
NDC 0009-5401

Generic Name
Nicotine
Dosage Form
Spray, Metered
Route
Nasal
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-provera
NDC 0009-7376

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
NDA
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

Sarclisa
NDC 0024-0654

Generic Name
Isatuximab
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Sarclisa
NDC 0024-0656

Generic Name
Isatuximab
Dosage Form
Injection, Solution, Concentrate
Route
Intravenous
Marketing
BLA
Active Listing
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
NDC Product
Human Prescription Drug

Jevtana
NDC 0024-5824

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

Dupixent
NDC 0024-5914

Generic Name
Dupilumab
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Carvedilol
NDC 0093-0051

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

Carvedilol
NDC 0093-0135

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

Diltiazem Hydrochloride
NDC 0093-0318

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

Diltiazem Hydrochloride
NDC 0093-0319

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

Diltiazem Hydrochloride
NDC 0093-0320

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

Diltiazem Hydrochloride
NDC 0093-0321

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

Cefprozil
NDC 0093-1077

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

Cefprozil
NDC 0093-1078

Generic Name
Cefprozil
Dosage Form
Tablet, Film Coated
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

Cephalexin
NDC 0093-2238

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

Cephalexin
NDC 0093-2240

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

Risedronate Sodium
NDC 0093-3098

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

Risedronate Sodium
NDC 0093-3099

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

Risedronate Sodium
NDC 0093-3100

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

Camrese
NDC 0093-3134

Generic Name
Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol
Dosage Form
Kit
Route
N/A
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Ketoconazole
NDC 0093-3219

Generic Name
Ketoconazole
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bisoprolol Fumarate And Hydrochlorothiazide
NDC 0093-3241

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

NDC 0093-3241

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

Viatris Specialty LLC

NDC Product
Human Prescription Drug

Dymista
NDC 0037-0245

Generic Name
Azelastine Hydrochloride And Fluticasone Propionate
Dosage Form
Spray, Metered
Route
Nasal
Marketing
NDA
Active Listing

Wyeth Pharmaceutical Division of Wyeth Holdings LLC

NDC Product
Vaccine

Trumenba
NDC 0005-0100

Generic Name
Meningococcal Group B Vaccine
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
BLA
Active Listing
NDC Product
Vaccine

Prevnar 20
NDC 0005-2000

Generic Name
Pneumococcal 20-valent Conjugate Vaccine
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
BLA
Active Listing

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

NDC Product
Human Prescription Drug

Besponsa
NDC 0008-0100

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

Protonix Delayed-release
NDC 0008-0841

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

Protonix Delayed-release
NDC 0008-0843

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

Protonix Delayed-release
NDC 0008-0844

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

Torisel
NDC 0008-1179

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

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