FDA Product

PROMETHAZINE HYDROCHLORIDE

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

Basic Information

Product Name

PROMETHAZINE HYDROCHLORIDE

FDA Product Code

68071-4424

Regulatory Information

NDC Product Code

68071-4424

Application Number

ANDA040712

Marketing Category

C73584

Effective Date

February 16, 2021

Territorial Authority

USA

FDA Title

PROMETHAZINE HYDROCHLORIDE TABLETS, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerNuCare Pharmaceuticals,Inc.

DUNS Number

010632300

Active Ingredients

PROMETHAZINE HYDROCHLORIDE

Quantity: 25 mg in 1 1

Code: R61ZEH7I1I

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

METHYLCELLULOSE (100 CPS)

Code: 4GFU244C4J

Class Code: IACT

Active Moieties

PROMETHAZINE

Code: FF28EJQ494

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