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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75987-031
Application NumberNDA022511
Product Classification
M
Marketing Category
C73594
G
Generic Name
Naproxen and Esomeprazole Magnesium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75987-030
Application NumberNDA022511
Product Classification
M
Marketing Category
C73594
G
Generic Name
Naproxen and Esomeprazole Magnesium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2023
FDA Product Classification
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