MedPath
FDA Product

Lansoprazole

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

Basic Information

Lansoprazole

16714-186

Regulatory Information

16714-186

ANDA210465

C73584

July 15, 2023

USA

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

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

NorthStar Rx LLC

830546433

Active Ingredients

lansoprazole

Quantity: 30 mg in 1 1

Code: 0K5C5T2QPG

Class Code: ACTIB

Crospovidone

Code: 2S7830E561

Class Code: IACT

Anhydrous Citric Acid

Code: XF417D3PSL

Class Code: IACT

Aspartame

Code: Z0H242BBR1

Class Code: IACT

Cellulose, Microcrystalline

Code: OP1R32D61U

Class Code: IACT

Low-Substituted Hydroxypropyl Cellulose, Unspecified

Code: 2165RE0K14

Class Code: IACT

Ethyl Acrylate and Methyl Methacrylate Copolymer Dispersion (2:1; 750000 MW 30% AQUEOUS)

Code: 8NT5GK8OOD

Class Code: IACT

Magnesium Carbonate

Code: 0E53J927NA

Class Code: IACT

Hypromellose 2910 (3 Mpa.S)

Code: 0VUT3PMY82

Class Code: IACT

Magnesium Stearate

Code: 70097M6I30

Class Code: IACT

Hypromellose 2910 (15 Mpa.S)

Code: 36SFW2JZ0W

Class Code: IACT

Methacrylic Acid and Ethyl Acrylate Copolymer

Code: NX76LV5T8J

Class Code: IACT

Glyceryl Monostearate

Code: 230OU9XXE4

Class Code: IACT

Ferric Oxide Red

Code: 1K09F3G675

Class Code: IACT

Ferric Oxide Yellow

Code: EX438O2MRT

Class Code: IACT

Mannitol

Code: 3OWL53L36A

Class Code: IACT

Sucrose

Code: C151H8M554

Class Code: IACT

Polyethylene Glycol 6000

Code: 30IQX730WE

Class Code: IACT

Polysorbate 80

Code: 6OZP39ZG8H

Class Code: IACT

Strawberry

Code: 4J2TY8Y81V

Class Code: IACT

talc

Code: 7SEV7J4R1U

Class Code: IACT

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

Triethyl Citrate

Code: 8Z96QXD6UM

Class Code: IACT

Hydroxypropyl Cellulose (90000 Wamw)

Code: UKE75GEA7F

Class Code: IACT

Sodium Hydroxide

Code: 55X04QC32I

Class Code: IACT

Active Moieties

lansoprazole

Code: 0K5C5T2QPG

© Copyright 2025. All Rights Reserved by MedPath