FDA Product

Promethazine Hydrochloride

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

Basic Information

Product Name

Promethazine Hydrochloride

FDA Product Code

0404-9942

Regulatory Information

NDC Product Code

0404-9942

Application Number

ANDA083312

Marketing Category

C73584

Effective Date

January 17, 2022

Territorial Authority

USA

FDA Title

Promethazine HCL 50 mg/mL Injection, USP 1 mL Single Dose Ampule

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

4

Company Information

ManufacturerHenry Schein, Inc.

DUNS Number

012430880

Active Ingredients

Promethazine Hydrochloride

Quantity: 50 mg in 1 mL

Code: R61ZEH7I1I

Class Code: ACTIB

Active Moieties

Promethazine

Code: FF28EJQ494

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