IBUPROFEN
IBUPROFEN 800 MG TABLETS
Approved
Approval ID
7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
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 Code43063-914
Application NumberANDA090796
Product Classification
M
Marketing Category
C73584
G
Generic Name
IBUPROFEN
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2023
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
IBUPROFENActive
Quantity: 800 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT