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
830546433
Active Ingredients
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