IBUPROFEN tablet, film coated

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

HOW SUPPLIED

600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 20 NDC: 51655-474-20, 30 NDC: 51655-474-52, 40 NDC: 51655-474-51, 60 NDC: 51655-474-25, and 90 NDC: 51655-474-90.

600 mg 30 count label

NDC: 51655-474-52

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51655-474(NDC:49483-603)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	600 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51655-474-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2020
2	NDC: 51655-474-25	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2020
3	NDC: 51655-474-51	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/08/2021
4	NDC: 51655-474-52	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/14/2021
5	NDC: 51655-474-26	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090796	11/13/2020

Labeler - Northwind Pharmaceuticals (036986393)

Registrant - Northwind Pharmaceuticals (036986393)

Establishment
Name	Address	ID/FEI	Business Operations
Northwind Pharmaceuticals		036986393	repack(51655-474)