Promethazine Hydrochloride
Summary of product characteristics
Effective Time
20221031
Version
5
Spl Product Data Elements
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
Application Number
ANDA040596
Brand Name
Promethazine Hydrochloride
Generic Name
Promethazine Hydrochloride
Product Ndc
65841-041
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
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
30 mins
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