Vimovo
These highlights do not include all the information needed to use VIMOVO safely and effectively. See full prescribing information for VIMOVO. VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
baa47781-7151-4c75-a9a2-d2eac0a7d55e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2023
Manufacturers
FDA
Horizon Therapeutics USA, Inc.
DUNS: 033470838
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naproxen and Esomeprazole Magnesium
PRODUCT DETAILS
NDC Product Code75987-031
Application NumberNDA022511
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJuly 25, 2023
Generic NameNaproxen and Esomeprazole Magnesium
INGREDIENTS (20)
NaproxenActive
Quantity: 375 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
Esomeprazole MagnesiumActive
Quantity: 20 mg in 1 1
Code: R6DXU4WAY9
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Naproxen and Esomeprazole Magnesium
PRODUCT DETAILS
NDC Product Code75987-030
Application NumberNDA022511
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJuly 25, 2023
Generic NameNaproxen and Esomeprazole Magnesium
INGREDIENTS (20)
Esomeprazole MagnesiumActive
Quantity: 20 mg in 1 1
Code: R6DXU4WAY9
Classification: ACTIM
NaproxenActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT