ibuprofen
Ibuprofen Tablets, USP These highlights do not include all the information needed to use ibuprofen safely and effectively.see full prescribing information for ibuprofen ibuprofen (ibuprofen) TABLET for ORAL use. Initial U.S. Approval:
Approved
Approval ID
ed1dc2d6-d0eb-4731-a0cd-31a64fe1ebd2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2015
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
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 Code67877-295
Application NumberANDA090796
Product Classification
M
Marketing Category
C73584
G
Generic Name
ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2015
FDA Product Classification
INGREDIENTS (10)
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
ibuprofenActive
Quantity: 600 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT