NEXIUM

Registrants (1)

AstraZeneca PLC

DUNS Number

230790719

Products (7)

NDC Product Code

0186-4025

Application Number

NDA021957

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 18, 2023

Ingredients

EsomeprazoleActive

Code: R6DXU4WAY9Class: ACTIMQuantity: 2.5 mg in 1 1

NEXIUM

NDC Product Code

0186-4050

Application Number

NDA021957

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 18, 2023

Ingredients

EsomeprazoleActive

Code: R6DXU4WAY9Class: ACTIMQuantity: 5 mg in 1 1

NEXIUM

NDC Product Code

0186-4040

Application Number

NDA021957

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 18, 2023

Ingredients

EsomeprazoleActive

Code: R6DXU4WAY9Class: ACTIMQuantity: 40 mg in 1 1

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POTASSIUM SORBATEInactive

Code: 1VPU26JZZ4Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

ANHYDROUS DEXTROSEInactive

Code: 5SL0G7R0OKClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

NEXIUM

NDC Product Code

0186-4010

Application Number

NDA022101

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 18, 2023

Ingredients

EsomeprazoleActive

Code: R6DXU4WAY9Class: ACTIMQuantity: 10 mg in 1 1

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POTASSIUM SORBATEInactive

Code: 1VPU26JZZ4Class: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

ANHYDROUS DEXTROSEInactive

Code: 5SL0G7R0OKClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

NEXIUM

NDC Product Code

0186-5040

Application Number

NDA021153

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 18, 2023

Ingredients

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

EsomeprazoleActive

Code: R6DXU4WAY9Class: ACTIMQuantity: 40 mg in 1 1

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

NEXIUM

NDC Product Code

0186-4020

Application Number

NDA021957

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 18, 2023

Ingredients

EsomeprazoleActive

Code: R6DXU4WAY9Class: ACTIMQuantity: 20 mg in 1 1

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POTASSIUM SORBATEInactive

Code: 1VPU26JZZ4Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ANHYDROUS DEXTROSEInactive

Code: 5SL0G7R0OKClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

NEXIUM

NDC Product Code

0186-5020

Application Number

NDA021153

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 18, 2023

Ingredients

EsomeprazoleActive

Code: R6DXU4WAY9Class: ACTIMQuantity: 20 mg in 1 1

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

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Registrants (1)

Products (7)

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