Label: PROMETHAZINE HYDROCHLORIDE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-588-53 - Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 68382-041
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 21, 2014
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PRINCIPAL DISPLAY PANEL
NDC: 51655-588-53
MFG: 68382-041-10
Promethazine Hydrochloride 25MG
10 tablets
Rx Only
Lot#: NW58820001
Exp. Date: 05/2015
Each tablet contains: Promethazine hydrochloride, USP....25mg
Dosage: See package insert
Store at 68 to 77 degrees F.
Store in a tight, light-resistant container (See USP).
Keep out of the reach of children.
Mfg by: Cadila Healthcare Ltd. India
Distributed by Zydus Pharmaceuticals USA, Inc Pennington, NJ 08534 Lot# MN5816
Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256
- WARNINGS AND PRECAUTIONS
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INGREDIENTS AND APPEARANCE
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-588(NDC:68382-041) Route of Administration oral Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE 25 mg in 30 Product Characteristics Color white Score 4 pieces Shape ROUND Size 8mm Flavor Imprint Code ZC02 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-588-53 10 in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040596 05/19/2014 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-588)