MedPath
FDA Product

Lansoprazole

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Lansoprazole

70756-806

Regulatory Information

70756-806

ANDA205868

C73584

March 28, 2022

USA

These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995

HUMAN PRESCRIPTION DRUG LABEL

14

Company Information

080268943

Active Ingredients

LANSOPRAZOLE

Quantity: 15 mg in 1 1

Code: 0K5C5T2QPG

Class Code: ACTIB

Inactive Ingredients

SUCROSE

Code: C151H8M554

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

HYDROXYPROPYL CELLULOSE

Code: RFW2ET671P

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

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

Code: NX76LV5T8J

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

MAGNESIUM CARBONATE

Code: 0E53J927NA

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

Active Moieties

LANSOPRAZOLE

Code: 0K5C5T2QPG

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