FDA Product

Diazepam

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Diazepam

FDA Product Code

70518-2358

Regulatory Information

NDC Product Code

70518-2358

Application Number

ANDA210363

Marketing Category

C73584

Effective Date

February 28, 2024

Territorial Authority

USA

FDA Title

DIAZEPAM INJECTION, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

8

Company Information

ManufacturerREMEDYREPACK INC.

DUNS Number

829572556

Active Ingredients

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

Quantity: 10 mg in 2 mL

Code: Q3JTX2Q7TU

Class Code: ACTIB

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

BENZOIC ACID

Code: 8SKN0B0MIM

Class Code: IACT

Active Moieties

DIAZEPAM

Code: Q3JTX2Q7TU

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