Promethazine Hydrochloride

Basic Information

Product Name

FDA Product Code

50090-4875

Regulatory Information

NDC Product Code

50090-4875

Application Number

ANDA040596

Marketing Category

C73584

Effective Date

November 12, 2022

Territorial Authority

USA

FDA Title

Promethazine Hydrochloride Tablets USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 2165RE0K14

Class Code: IACT

PROMETHAZINE HYDROCHLORIDE

Quantity: 25 mg in 1 1

Code: R61ZEH7I1I

Class Code: ACTIB

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

Active Moieties

PROMETHAZINE

Code: FF28EJQ494

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Active Moieties

PROMETHAZINE