Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen and famotidine
Product Details
NDC Product Code
63629-8891Application Number
ANDA211890Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 24, 2021IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FamotidineActive
Code: 5QZO15J2Z8Class: ACTIBQuantity: 26.6 mg in 1 1
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT