Active ingredient
Lansoprazole
124 finished FDA listings contain Lansoprazole as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LANSOPRAZOLE
- Dosage forms
- Capsule, Delayed Release, Capsule, Delayed Release Pellets, Tablet, Orally Disintegrating, Tablet, Orally Disintegrating, Delayed Release
- Routes
- Oral
- Manufacturers / labelers
- 62
- Strengths listed
- 15 mg/1 · 30 mg/1
- Brand names in FDA listings
- Basic Care Lansoprazole, Berkley And Jensen Lansoprazole, Careone Acid Reducer, Dg Health Lansoprazole, Equaline Lansoprazole, Equate Lansoprazole, Equate Lansoprazole Delayed Release, Foster And Thrive Acid Reducer, Good Neighbor Pharmacy Lansoprazole, Good Sense Lansoprazole, Kirkland Signature Lansoprazole, Lansoprazole Dr, Members Mark Lansoprazole, Prevacid, Prevacid 24 Hr, Prevacid Solutab, Topcare Lansoprazole, Up And Up Lansoprazole
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 17128
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020406 | TAKEDA PHARMS USA | 1995-05-10 | 1 |
| NDA 021428 | TAKEDA PHARMS USA | 2002-08-30 | 2 |
| ANDA 077255 | TEVA PHARMS | 2009-11-10 | 3 |
| ANDA 090763 | MYLAN PHARMS INC | 2009-11-10 | 5 |
| ANDA 091269 | DR REDDYS LABS LTD | 2010-10-15 | 16 |
| ANDA 202319 | PERRIGO R AND D | 2012-05-18 | 23 |
| ANDA 202194 | DR REDDYS LABS LTD | 2012-05-18 | 8 |
| ANDA 201921 | NATCO PHARMA LTD | 2012-12-18 | 1 |
| ANDA 203187 | MYLAN | 2016-06-01 | 2 |
| NDA 208025 | DEXCEL | 2016-06-07 | 8 |
| ANDA 203203 | XIROMED | 2016-07-25 | 13 |
| ANDA 203957 | AJANTA PHARMA LTD | 2016-10-14 | 2 |
| ANDA 205868 | ADAPTIS | 2017-08-30 | 10 |
| ANDA 208784 | TEVA PHARMS USA | 2017-09-21 | 3 |
| ANDA 200816 | ZYDUS PHARMS | 2018-11-27 | 4 |
| ANDA 202396 | MYLAN | 2018-11-28 | 2 |
| ANDA 207394 | ALKEM LABS LTD | 2019-01-18 | 5 |
| ANDA 203083 | HETERO LABS LTD III | 2020-05-18 | 7 |
| ANDA 210465 | DR REDDYS | 2021-02-01 | 2 |
| ANDA 207167 | AUROBINDO PHARMA LTD | 2023-03-28 | 5 |
| ANDA 208671 | MACLEODS PHARMS | 2024-11-04 | 2 |
Official labeling on DailyMed
- LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [CARDINAL HEALTH 107, LLC] · version 1 · 2026-09-02
- LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA, INC.] · version 26 · 2026-08-25
- LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [AMAZON.COM SERVICES LLC] · version 2 · 2026-08-24
- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-08-14
- LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMAZON.COM SERVICES LLC] · version 2 · 2026-08-10
- LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREENS COMPANY] · version 5 · 2026-07-31
- LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC.] · version 9 · 2026-07-27
- LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] · version 13 · 2026-07-27
- LANSOPRAZOLE CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION] · version 5 · 2026-07-24
- LANSOPRAZOLE CAPSULE, DELAYED RELEASE [RUGBY LABORATORIES, INC] · version 6 · 2026-07-20
- LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REDPHARM DRUG] · version 1 · 2026-07-20
- LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [NORTHSTAR RX LLC] · version 4 · 2026-07-17
Showing the 12 most recent of 105 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.