MedPath
FDA Product

Lansoprazole

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

Basic Information

Lansoprazole

71335-1820

Regulatory Information

71335-1820

ANDA203203

C73584

April 15, 2022

USA

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for .

HUMAN PRESCRIPTION DRUG LABEL

102

Company Information

171714327

Active Ingredients

LANSOPRAZOLE

Quantity: 30 mg in 1 1

Code: 0K5C5T2QPG

Class Code: ACTIB

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

Code: NX76LV5T8J

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

POLYSORBATE 20

Code: 7T1F30V5YH

Class Code: IACT

MAGNESIUM CARBONATE

Code: 0E53J927NA

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

LANSOPRAZOLE

Code: 0K5C5T2QPG

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