FDA Product

Promethazine Hydrochloride

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

Basic Information

Product Name

Promethazine Hydrochloride

FDA Product Code

43063-060

Regulatory Information

NDC Product Code

43063-060

Application Number

ANDA040500

Marketing Category

C73584

Effective Date

September 19, 2023

Territorial Authority

USA

FDA Title

Promethazine Hydrochloride Suppositories USP, 25 mg

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

16

Company Information

ManufacturerPD-Rx Pharmaceuticals, Inc.

DUNS Number

156893695

Active Ingredients

PROMETHAZINE HYDROCHLORIDE

Quantity: 25 mg in 1 1

Code: R61ZEH7I1I

Class Code: ACTIB

ASCORBYL PALMITATE

Code: QN83US2B0N

Class Code: IACT

COCOA BUTTER

Code: 512OYT1CRR

Class Code: IACT

WHITE WAX

Code: 7G1J5DA97F

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

PROMETHAZINE

Code: FF28EJQ494

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