Diphenhydramine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 608775388

Effective Date

October 3, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Fresenius Kabi USA, LLC

DUNS Number

840771732

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

63323-664

Application Number

ANDA040466

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

October 3, 2019

Ingredients

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

Code: TC2D6JAD40Class: ACTIBQuantity: 50 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT