Label: IBUPROFEN tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-049-24 - Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 53746-464
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 20, 2014
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PRINCIPAL DISPLAY PANEL
NDC: 51655-049-24
MFG: 53746-464-05
Ibuprofen 400 MG
30 Tablets
Rx Only
Lot# NW47730002
Exp. Date: 11/2015
Each film coated tablet contains: ibuprofen, USP....400 mg
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: Amneal Pharmaceuticals of NY Hauppage, NY 11788 Lot: HL41013
Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256
- WARNINGS AND PRECAUTIONS
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-049(NDC:53746-464) Route of Administration oral Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 400 mg in 30 Product Characteristics Color white Score no score Shape ROUND Size 13mm Flavor Imprint Code IP464 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-049-24 30 in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078558 05/20/2014 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-049)