DUEXIS
These highlights do not include all the information needed to use DUEXIS safely and effectively. See full prescribing information for DUEXIS. DUEXIS (ibuprofen and famotidine) tablets, for oral useInitial U.S. Approval: 2011
Approved
Approval ID
558b9f26-37b2-423b-932d-25a37afe57ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2023
Manufacturers
FDA
Horizon Therapeutics USA, Inc.
DUNS: 033470838
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 Code75987-010
Application NumberNDA022519
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ibuprofen and Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2021
FDA Product Classification
INGREDIENTS (17)
IBUPROFENActive
Quantity: 800 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
FAMOTIDINEActive
Quantity: 26.6 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT