LANSOPRAZOLE

These highlights do not include all the information needed to use Lansoprazole Delayed-Release Capsules and Lansoprazole Delayed-Release Orally Disintegrating Tablets safely and effectively. See full prescribing information for: Lansoprazole Delayed-Release CapsulesLansoprazole Delayed-Release Orally Disintegrating Tablets For oral administrationInitial U.S. Approval: 1995

Approved

Approval ID

40c43d5a-7523-4ff1-863b-ed0c10a238f7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 29, 2011

Manufacturers

FDA

STAT Rx USA LLC

DUNS: 786036330

Products 2

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

LANSOPRAZOLE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code16590-891

Application NumberNDA020406

Product Classification

Marketing Category

C73605

Generic Name

LANSOPRAZOLE

Product Specifications

Route of AdministrationORAL

Effective DateNovember 9, 2011

FDA Product Classification

INGREDIENTS (15)

SUCROSEInactive

Code: C151H8M554

Classification: IACT

LANSOPRAZOLEActive

Quantity: 30 mg in 1 1

Code: 0K5C5T2QPG

Classification: ACTIB

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

Code: NX76LV5T8J

Classification: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive

Code: 2165RE0K14

Classification: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NA

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

LANSOPRAZOLE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code16590-890

Application NumberNDA020406

Product Classification

Marketing Category

C73605

Generic Name

LANSOPRAZOLE

Product Specifications

Route of AdministrationORAL

Effective DateNovember 9, 2011

FDA Product Classification

INGREDIENTS (16)

LANSOPRAZOLEActive

Quantity: 15 mg in 1 1

Code: 0K5C5T2QPG

Classification: ACTIB

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive

Code: 2165RE0K14

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

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

Code: NX76LV5T8J

Classification: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NA

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

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LANSOPRAZOLE

Products 2

LANSOPRAZOLE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

LANSOPRAZOLE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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