Esomeprazole Magnesium

These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM FOR DELAYED-RELEASE ORAL SUSPENSION safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM FOR DELAYED-RELEASE ORAL SUSPENSION. ESOMEPRAZOLE MAGNESIUM for delayed-release oral suspension Initial U.S. Approval: 1989 (omeprazole)

Approved

Approval ID

190a4c5b-1547-45d7-b00b-10da4131e2e2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 17, 2023

Manufacturers

FDA

Zydus Pharmaceuticals USA Inc.

DUNS: 156861945

Products 2

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 Code68382-848

Application NumberANDA206055

Product Classification

Marketing Category

C73584

Generic Name

Esomeprazole Magnesium

Product Specifications

Route of AdministrationORAL

Effective DateAugust 17, 2023

FDA Product Classification

INGREDIENTS (17)

ESOMEPRAZOLE MAGNESIUM DIHYDRATEActive

Quantity: 20 mg in 1 1

Code: 36H71644EQ

Classification: ACTIM

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

DEXTROSEInactive

Code: IY9XDZ35W2

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

STRAWBERRYInactive

Code: 4J2TY8Y81V

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

Esomeprazole Magnesium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68382-849

Application NumberANDA206055

Product Classification

Marketing Category

C73584

Generic Name

Esomeprazole Magnesium

Product Specifications

Route of AdministrationORAL

Effective DateAugust 17, 2023

FDA Product Classification

INGREDIENTS (17)

ESOMEPRAZOLE MAGNESIUM DIHYDRATEActive

Quantity: 40 mg in 1 1

Code: 36H71644EQ

Classification: ACTIM

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

DEXTROSEInactive

Code: IY9XDZ35W2

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

HYDROXYPROPYL CELLULOSE (TYPE E)Inactive

Code: 66O7AQV0RT

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

STRAWBERRYInactive

Code: 4J2TY8Y81V

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

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Esomeprazole Magnesium

Products 2

Esomeprazole Magnesium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Esomeprazole Magnesium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

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