IBUPROFEN AND FAMOTIDINE
These highlights do not include all the information needed to use IBUPROFEN and FAMOTIDINE TABLETS safely and effectively. See full prescribing information for IBUPROFEN and FAMOTIDINE TABLETS. IBUPROFEN and FAMOTIDINE tablets, for oral use Initial U.S. Approval: 2011
Approved
Approval ID
03733e49-7db4-4d98-b363-d0d23686ec72
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2023
Manufacturers
FDA
Ascent Pharmaceuticals, Inc.
DUNS: 080938961
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen and famotidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-544
Application NumberANDA216814
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen and famotidine
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2022
FDA Product Classification
INGREDIENTS (13)
IBUPROFENActive
Quantity: 800 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
FAMOTIDINEActive
Quantity: 26.6 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT