IBUPROFEN- ibuprofen tablet, film coated
Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

MEDGUIDE IBUPROFEN TABLETS

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side)

Bottles of 30: NDC 70934-509-30

NDC: 70934-509-30

Label

IBUPROFEN
ibuprofen tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	400 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70934-509-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/09/2020	10/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090796	04/09/2020	10/31/2021

Labeler - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)

Registrant - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)

Name	Address	ID/FEI	Business Operations
Establishment
Denton Pharma, Inc. DBA Northwind Pharmaceuticals		080355546	repack(70934-509)

Revised: 1/2023

Document Id: f19e0d94-84e2-b5c8-e053-2995a90a4047

Set id: a8daf71f-1757-8aa8-e053-2a95a90adb86

Version: 2

Effective Time: 20230106

Denton Pharma, Inc. DBA Northwind Pharmaceuticals