IBUPROFEN
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS
Approved
Approval ID
95830141-2439-9d45-e053-2995a90ae084
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2023
Manufacturers
FDA
St. Mary's Medical Park Pharmacy
DUNS: 063050751
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
IBUPROFEN
PRODUCT DETAILS
NDC Product Code60760-603
Application NumberANDA090796
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 17, 2023
Generic NameIBUPROFEN
INGREDIENTS (10)
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
IBUPROFENActive
Quantity: 600 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT