Ibuprofen
ibuprofen
Approved
Approval ID
6a1178c8-58df-f959-e053-2a91aa0ab6f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2022
Manufacturers
FDA
RedPharm Drug, Inc.
DUNS: 828374897
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-1588
Application NumberANDA091625
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
IBUPROFENActive
Quantity: 400 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT