POLYETHYLENE GLYCOL 400
UNII B697894SGQ

Substance Identification & Data

This profile provides standardized clinical and technical data for Polyethylene Glycol 400, uniquely identified by the FDA Unique Ingredient Identifier (UNII) B697894SGQ.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 25322-68-3 and the RxNorm Concept ID (RxCUI) 8514. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
B697894SGQ
CAS Registry Number
25322-68-3
RxNorm Concept ID
8514

Detailed Substance Profile

Preferred Name
POLYETHYLENE GLYCOL 400
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
B697894SGQ
The specific atomic composition represented as a molecular structure string.
NCI Thesaurus
C84080
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 Polyethylene Glycol 400. 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-8

Common Names & Synonyms

CARBOWAX PEG 400
MACROGOL 400
MACROGOL 400 [JAN]
MACROGOL 400 [WHO-DD]
OCTAETHYLENE GLYCOL
PEG 400
PEG-400 [VANDF]
PEG-8 [VANDF]
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 400 [II]
POLYETHYLENE GLYCOL 400 [USP-RS]
POLYETHYLENE GLYCOL 400 [VANDF]
POLYETHYLENE GLYCOL 8
POLYETHYLENE GLYCOL 8 [VANDF]

Brand / Trade Names

BOTANIPEG 400
HETOXIDE EG-400
JEECHEM 400
LIPO POLYGLYCOL 400
LIPOXOL 400 MED
LUMULSE PEG 400
PLURACARE E 400
POLYGLYKOL 400
PROTACHEM 400
SYMPATENS-PEG/400
TOHO PEG NO. 400
UNIPEG-400 X
UPIWAX 400

Technical Codes

NSC-152325
NSC-155081
NSC-32853
NSC-32854
NSC-32855
NSC-32856
NSC-35744
NSC-35745
NSC-35746
NSC-35747
NSC-35748
NSC-35749
NSC-57859

NDC Products Containing POLYETHYLENE GLYCOL 400

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. 2
→ Actavis Pharma, Inc. 6
→ Alcon Laboratories, Inc. 10
→ Alcon Research Ltd 1
→ Amneal Pharmaceuticals of New York LLC 2
→ AstraZeneca Pharmaceuticals LP 2
→ Bausch Health US, LLC 2
→ E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 1
→ E.R. Squibb & Sons, L.L.C. 3
→ Eli Lilly and Company 1
→ Fougera Pharmaceuticals, LLC 1
→ Genentech, Inc. 4
→ GlaxoSmithKline LLC 11
→ Haleon US Holdings LLC 56
→ Hikma Pharmaceuticals USA Inc. 6
→ L Perrigo Company 1
→ L. Perrigo Company 1
→ Merck Sharp & Dohme LLC 4
→ Mission Pharmacal Company 5
→ Novartis Pharmaceuticals Corporation 10
→ PAI Holdings, LLC dba PAI Pharma 6
→ Parke-Davis Div of Pfizer Inc 1
→ Pfizer Laboratories Div Pfizer Inc 13
→ Sanofi-Aventis U.S. LLC 1
→ Teva Pharmaceuticals USA, Inc. 38
→ Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 12

AbbVie Inc.

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

Kaletra
NDC 0074-6799

Generic Name
Lopinavir And Ritonavir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

Actavis Pharma, Inc.

NDC Product
Human Prescription Drug

Lamotrigine
NDC 0228-1422

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

Lamotrigine
NDC 0228-1453

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

Lamotrigine
NDC 0228-1580

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

Lamotrigine
NDC 0228-1638

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

NDC 0228-3315

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

Doxepin
NDC 0228-3315

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

Alcon Laboratories, Inc.

NDC Product
Human Otc Drug

Systane Lubricant
NDC 0065-0429

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane
NDC 0065-0454

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Gel
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
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 Otc Drug

Systane Ultra
NDC 0065-1431

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Ultra
NDC 0065-1432

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Hydration Pf Preservative Free
NDC 0065-1437

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Day And Night Value Pack
NDC 0065-1502

Generic Name
Polyethylene Glycol 400, Propylene Glycol 0.3%
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Ultra Preservative Free
NDC 0065-1507

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Hydration Pf Preservative Free
NDC 0065-1510

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Genteal Tears Gel Drops
NDC 0065-8067

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Gel
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing

Alcon Research Ltd

NDC Product
Human Otc Drug

Systane
NDC 0065-0431

Generic Name
Polyethylene Glycol And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing

Amneal Pharmaceuticals of New York LLC

NDC Product
Human Prescription Drug

Cyclobenzaprine Hydrochloride
NDC 0115-1436

Generic Name
Cyclobenzaprine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Cyclobenzaprine Hydrochloride
NDC 0115-1437

Generic Name
Cyclobenzaprine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing

AstraZeneca Pharmaceuticals LP

NDC Product
Human Prescription Drug

Brilinta
NDC 0186-0776

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

Brilinta
NDC 0186-0777

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

Bausch Health US, LLC

NDC Product
Human Prescription Drug

Targretin
NDC 0187-5525

Generic Name
Bexarotene
Dosage Form
Gel
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Targretin
NDC 0187-5526

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

E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

NDC Product
Human Prescription Drug

Clindamycin Phosphate
NDC 0168-0202

Generic Name
Clindamycin Phosphate
Dosage Form
Gel
Route
Topical
Marketing
ANDA
Active Listing

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

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

Eli Lilly and Company

NDC Product
Human Prescription Drug

Evista
NDC 0002-4184

Generic Name
Raloxifene Hydrochloride
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing

Fougera Pharmaceuticals, LLC

NDC Product
Human Prescription Drug

Metronidazole
NDC 0168-0383

Generic Name
Metronidazole
Dosage Form
Lotion
Route
Topical
Marketing
ANDA
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

GlaxoSmithKline LLC

NDC Product
Human Prescription Drug

Malarone
NDC 0173-0675

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

Malarone
NDC 0173-0676

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

Lamictal Xr
NDC 0173-0754

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

Lamictal Xr
NDC 0173-0755

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

Lamictal Xr
NDC 0173-0756

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

Lamictal Xr
NDC 0173-0757

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

Lamictal Xr
NDC 0173-0758

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

Lamictal Xr
NDC 0173-0759

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

Lamictal Xr
NDC 0173-0760

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

Lamictal Xr
NDC 0173-0761

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

Lamictal Xr
NDC 0173-0781

Generic Name
Lamotrigine
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA
Active Listing

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Sensodyne Pronamel Daily Protection
NDC 0135-0460

Generic Name
Potassium Nitrate And Sodium Fluoride
Dosage Form
Paste
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Advanced Whitening
NDC 0135-0479

Generic Name
Potassium Nitrate
Dosage Form
Paste
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Pronamel Gentle Whitening
NDC 0135-0484

Generic Name
Potassium Nitrate And Sodium Fluoride
Dosage Form
Paste
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Pronamel Fresh Breath
NDC 0135-0520

Generic Name
Potassium Nitrate And Sodium Fluoride
Dosage Form
Paste
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Extra Whitening
NDC 0135-0525

Generic Name
Potassium Nitrate And Sodium Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Fresh Mint
NDC 0135-0529

Generic Name
Potassium Nitrate And Sodium Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Repair And Protect
NDC 0135-0548

Generic Name
Stannous Fluoride
Dosage Form
Paste
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne
NDC 0135-0550

Generic Name
Potassium Nitrate And Sodium Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Biotene Fresh Mint Original
NDC 0135-0557

Generic Name
Sodium Fluoride
Dosage Form
Paste
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Biotene Gentle Mint
NDC 0135-0558

Generic Name
Sodium Fluoride
Dosage Form
Paste
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Pronamel Multi Action
NDC 0135-0568

Generic Name
Potassium Nitrate And Sodium Fluoride
Dosage Form
Paste
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Complete Protection
NDC 0135-0573

Generic Name
Stannous Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne True White
NDC 0135-0579

Generic Name
Potassium Nitrate And Sodium Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne True White
NDC 0135-0581

Generic Name
Potassium Nitrate And Sodium Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Aquafresh Cavity Protection
NDC 0135-0590

Generic Name
Sodium Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne
NDC 0135-0593

Generic Name
Potassium Nitrate And Sodium Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Parodontax
NDC 0135-0598

Generic Name
Stannous Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Parodontax
NDC 0135-0601

Generic Name
Stannous Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Rapid Relief
NDC 0135-0621

Generic Name
Stannous Fluoride
Dosage Form
Paste
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Rapid Relief
NDC 0135-0622

Generic Name
Stannous Fluoride
Dosage Form
Paste
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Parodontax Complete Protection
NDC 0135-0627

Generic Name
Stannous Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Parodontax Complete Protection
NDC 0135-0634

Generic Name
Stannous Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Parodontax Active Gum Repair
NDC 0135-0637

Generic Name
Stannous Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Extra Whitening Cool Mint
NDC 0135-0643

Generic Name
Potassium Nitrate And Sodium Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Parodontax Gum Strengthen And Protect
NDC 0135-0655

Generic Name
Stannous Fluoride
Dosage Form
Paste, Dentifrice
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Polident Propartial
NDC 0135-0710

Generic Name
Stannous Fluoride
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Pronamel Kids Bubble Mint
NDC 0135-0818

Generic Name
Sodium Fluoride
Dosage Form
Paste, Dentifrice
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Advanced Whitening Plus
NDC 0135-5029

Generic Name
Potassium Nitrate
Dosage Form
Paste
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Fresh Clean
NDC 0135-5912

Generic Name
Stannous Fluoride
Dosage Form
Paste, Dentifrice
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sensodyne Whiten And Shine
NDC 0135-5913

Generic Name
Stannous Fluoride
Dosage Form
Paste, Dentifrice
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Icosapent Ethyl
NDC 0054-0508

Generic Name
Icosapent Ethyl
Dosage Form
Capsule
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

Diazepam Intensol
NDC 0054-3185

Generic Name
Diazepam Intensol
Dosage Form
Solution, Concentrate
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 All Day Allergy
NDC 0113-0981

Generic Name
Cetirizine Hydrochloride
Dosage Form
Capsule, Liquid Filled
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

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

Mission Pharmacal Company

NDC Product
Human Prescription Drug

Avar-e Green
NDC 0178-0460

Generic Name
Sulfacetamide Sodium, Sulfur
Dosage Form
Cream
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Avar-e Ls
NDC 0178-0465

Generic Name
Sulfacetamide Sodium, Sulfur
Dosage Form
Cream
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Avar-e
NDC 0178-0470

Generic Name
Sulfacetamide Sodium, Sulfur
Dosage Form
Cream
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Ovaceplus Plus
NDC 0178-0495

Generic Name
Sulfacetamide Sodium
Dosage Form
Cream
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Ovace Plus
NDC 0178-0620

Generic Name
Sulfacetamide Sodium
Dosage Form
Lotion
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing

Novartis Pharmaceuticals Corporation

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

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

Rydapt
NDC 0078-0698

Generic Name
Rydapt
Dosage Form
Capsule, Liquid Filled
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

Tabrecta
NDC 0078-0716

Generic Name
Capmatinib
Dosage Form
Tablet, Film Coated
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

PAI Holdings, LLC dba PAI Pharma

NDC Product
Human Prescription Drug

Potassium Citrate And Citric Acid
NDC 0121-0676

Generic Name
Potassium Citrate And Citric Acid Monohydrate
Dosage Form
Solution
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Otc Drug

Acetaminophen
NDC 0121-1047

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

Mupirocin
NDC 0121-1076

Generic Name
Mupirocin
Dosage Form
Ointment
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Benzocaine 20%
NDC 0121-1077

Generic Name
Benzocaine 20%
Dosage Form
Solution
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Acetaminophen
NDC 0121-2094

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

Acetaminophen
NDC 0121-3141

Generic Name
Acetaminophen
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Parke-Davis Div of Pfizer Inc

NDC Product
Human Prescription Drug

Zarontin
NDC 0071-0237

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

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Aldactone
NDC 0025-1001

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

Aldactone
NDC 0025-1031

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

Aldactone
NDC 0025-1041

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

Talzenna
NDC 0069-0252

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Talzenna
NDC 0069-0353

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Talzenna
NDC 0069-0454

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Talzenna
NDC 0069-0546

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Talzenna
NDC 0069-0655

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Talzenna
NDC 0069-0757

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
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
NDC Product
Human Prescription Drug

Vyndamax
NDC 0069-8730

Generic Name
Tafamidis
Dosage Form
Capsule, Liquid Filled
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
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

Ketorolac Tromethamine
NDC 0093-0314

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

NDC 0093-0314

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

Mupirocin
NDC 0093-1010

Generic Name
Mupirocin
Dosage Form
Ointment
Route
Topical
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

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

Cyclobenzaprine Hydrochloride
NDC 0093-1920

Generic Name
Cyclobenzaprine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Cyclobenzaprine Hydrochloride
NDC 0093-1921

Generic Name
Cyclobenzaprine Hydrochloride
Dosage Form
Capsule, Extended Release
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
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

Reclipsen 28 Day
NDC 0093-3304

Generic Name
Desogestrel And Ethinyl Estradiol
Dosage Form
Kit
Route
N/A
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Mimvey
NDC 0093-5455

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

Erythromycin
NDC 0093-5571

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

NDC 0093-5571

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

NDC 0093-5572

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

Erythromycin
NDC 0093-5572

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

Rivelsa
NDC 0093-6031

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

Camrese Lo
NDC 0093-6148

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

Carvedilol
NDC 0093-7295

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

Carvedilol
NDC 0093-7296

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

Venlafaxine Hydrochloride
NDC 0093-7384

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

Venlafaxine Hydrochloride
NDC 0093-7385

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

Venlafaxine Hydrochloride
NDC 0093-7386

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

Anastrozole
NDC 0093-7536

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

Vardenafil Hydrochloride
NDC 0093-7652

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

Vardenafil Hydrochloride
NDC 0093-7653

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

Vardenafil Hydrochloride
NDC 0093-7654

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

Vardenafil Hydrochloride
NDC 0093-7655

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

Levocetirizine Dihydrochloride
NDC 0093-7701

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

Irbesartan And Hydrochlorothiazide
NDC 0093-8232

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

Irbesartan And Hydrochlorothiazide
NDC 0093-8238

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

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

NDC Product
Human Prescription Drug

Duavee
NDC 0008-1123

Generic Name
Conjugated Estrogens/bazedoxifene
Dosage Form
Tablet, Film Coated
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
NDC Product
Human Prescription Drug

Premarin
NDC 0046-1100

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

Premarin
NDC 0046-1101

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

Premarin
NDC 0046-1102

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

Premarin
NDC 0046-1103

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

Premarin
NDC 0046-1104

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

Prempro
NDC 0046-1105

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prempro
NDC 0046-1106

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prempro
NDC 0046-1107

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prempro
NDC 0046-1108

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Premphase
NDC 0046-2575

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing

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