FDA Product

Diphenhydramine Hydrochloride

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

Basic Information

Product Name

Diphenhydramine Hydrochloride

FDA Product Code

68083-611

Regulatory Information

NDC Product Code

68083-611

Application Number

ANDA218448

Marketing Category

C73584

Effective Date

March 22, 2024

Territorial Authority

USA

FDA Title

Diphenhydramine Hydrochloride Injection, USP Rx only

Labeling Type

Human Prescription Drug Label

Version Number

2

Company Information

ManufacturerGland Pharma Limited

DUNS Number

918601238

Active Ingredients

DIPHENHYDRAMINE HYDROCHLORIDE

Quantity: 50 mg in 1 mL

Code: TC2D6JAD40

Class Code: ACTIB

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

DIPHENHYDRAMINE

Code: 8GTS82S83M

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