NEXIUM

These highlights do not include all the information needed to use NEXIUM safely and effectively. See full prescribing information for NEXIUM. NEXIUM (esomeprazole magnesium) delayed-release capsules, for oral use NEXIUM (esomeprazole magnesium) for delayed-release oral suspensionInitial U.S. Approval: 1989 (omeprazole)

Approved

Approval ID

f4853677-1622-4037-688b-fdf533a11d96

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 18, 2023

Manufacturers

FDA

AstraZeneca Pharmaceuticals LP

DUNS: 938368834

Products 7

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Esomeprazole magnesium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0186-4025

Application NumberNDA021957

Product Classification

Marketing Category

C73594

Generic Name

Esomeprazole magnesium

Product Specifications

Route of AdministrationORAL

Effective DateJuly 18, 2023

FDA Product Classification

INGREDIENTS (1)

ESOMEPRAZOLE MAGNESIUMActive

Quantity: 2.5 mg in 1 1

Code: R6DXU4WAY9

Classification: ACTIM

Esomeprazole magnesium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0186-4050

Application NumberNDA021957

Product Classification

Marketing Category

C73594

Generic Name

Esomeprazole magnesium

Product Specifications

Route of AdministrationORAL

Effective DateJuly 18, 2023

FDA Product Classification

INGREDIENTS (1)

ESOMEPRAZOLE MAGNESIUMActive

Quantity: 5 mg in 1 1

Code: R6DXU4WAY9

Classification: ACTIM

Esomeprazole magnesium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0186-4040

Application NumberNDA021957

Product Classification

Marketing Category

C73594

Generic Name

Esomeprazole magnesium

Product Specifications

Route of AdministrationORAL

Effective DateJuly 18, 2023

FDA Product Classification

INGREDIENTS (15)

ESOMEPRAZOLE MAGNESIUMActive

Quantity: 40 mg in 1 1

Code: R6DXU4WAY9

Classification: ACTIM

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POTASSIUM SORBATEInactive

Code: 1VPU26JZZ4

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

ANHYDROUS DEXTROSEInactive

Code: 5SL0G7R0OK

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

Esomeprazole magnesium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0186-4010

Application NumberNDA022101

Product Classification

Marketing Category

C73594

Generic Name

Esomeprazole magnesium

Product Specifications

Route of AdministrationORAL

Effective DateJuly 18, 2023

FDA Product Classification

INGREDIENTS (15)

ESOMEPRAZOLE MAGNESIUMActive

Quantity: 10 mg in 1 1

Code: R6DXU4WAY9

Classification: ACTIM

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POTASSIUM SORBATEInactive

Code: 1VPU26JZZ4

Classification: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

ANHYDROUS DEXTROSEInactive

Code: 5SL0G7R0OK

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

Esomeprazole magnesium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0186-5040

Application NumberNDA021153

Product Classification

Marketing Category

C73594

Generic Name

Esomeprazole magnesium

Product Specifications

Route of AdministrationORAL

Effective DateJuly 18, 2023

FDA Product Classification

INGREDIENTS (21)

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

ESOMEPRAZOLE MAGNESIUMActive

Quantity: 40 mg in 1 1

Code: R6DXU4WAY9

Classification: ACTIM

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

Esomeprazole magnesium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0186-4020

Application NumberNDA021957

Product Classification

Marketing Category

C73594

Generic Name

Esomeprazole magnesium

Product Specifications

Route of AdministrationORAL

Effective DateJuly 18, 2023

FDA Product Classification

INGREDIENTS (15)

ESOMEPRAZOLE MAGNESIUMActive

Quantity: 20 mg in 1 1

Code: R6DXU4WAY9

Classification: ACTIM

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POTASSIUM SORBATEInactive

Code: 1VPU26JZZ4

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ANHYDROUS DEXTROSEInactive

Code: 5SL0G7R0OK

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

Esomeprazole magnesium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0186-5020

Application NumberNDA021153

Product Classification

Marketing Category

C73594

Generic Name

Esomeprazole magnesium

Product Specifications

Route of AdministrationORAL

Effective DateJuly 18, 2023

FDA Product Classification

INGREDIENTS (21)

ESOMEPRAZOLE MAGNESIUMActive

Quantity: 20 mg in 1 1

Code: R6DXU4WAY9

Classification: ACTIM

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

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NEXIUM

Products 7

Esomeprazole magnesium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (1)

Esomeprazole magnesium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (1)

Esomeprazole magnesium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Esomeprazole magnesium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Esomeprazole magnesium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

Esomeprazole magnesium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Esomeprazole magnesium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

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