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Promethazine hydrochloride - Medication Information

Product NDC Code 65841-042
Drug Name

Promethazine hydrochloride

Type Generic
Pharm Class Phenothiazine [EPC],
Phenothiazines [CS]
Active Ingredients
Promethazine hydrochloride 50 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 992438,
992447,
992475
Application Number ANDA040596
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-042-01 100 tablet in 1 bottle (65841-042-01)
65841-042-05 500 tablet in 1 bottle (65841-042-05)
65841-042-10 1000 tablet in 1 bottle (65841-042-10)
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Spl product data elements

Usually a list of ingredients in a drug product.
Promethazine Hydrochloride Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE PROMETHAZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED WHITE TO OFF-WHITE ROUND ZC;01 Promethazine Hydrochloride Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE PROMETHAZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED WHITE TO OFF-WHITE ROUND Z;C;0;2 Promethazine Hydrochloride Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE PROMETHAZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED WHITE TO OFF-WHITE ROUND ZC03

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-040-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 12.5 mg R x only 100 tablets NDC 65841-041-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 25 mg R x only 100 tablets NDC 65841-042-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 50 mg R x only 100 tablets Promethzine Tablets, 12.5 mg Promethazine Tablets, 25 mg Promethazine Tablets, 50 mg

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API