Quick answers
- What is Lansoprazole used for?
- The FDA-approved label (Prevacid, Takeda Pharmaceuticals America, Inc., July 8, 2025) says: “PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: Treatment of active duodenal ulcer in adults. Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. Maintenance of healed duodenal ulcers in adults. Treatment of active benign gastric ulcer in adults. Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lansoprazole have a boxed warning?
- No. None of the 60 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lansoprazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lansoprazole been recalled?
- FDA enforcement reports list 8 recalls of products of this medicine; the newest started March 23, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Lansoprazole?
- 32 companies list prescription products of Lansoprazole in the FDA NDC Directory, including Bryant Ranch Prepack, NuCare Pharmaceuticals, Inc. and A-S Medication Solutions.
What Lansoprazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: Treatment of active duodenal ulcer in adults. Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. Maintenance of healed duodenal ulcers in adults. Treatment of active benign gastric ulcer in adults. Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. …
— FDA label: Prevacid, Takeda Pharmaceuticals America, Inc., effective July 8, 2025. Read the full label on DailyMed →
The FDA has 60 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 60 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, delayed release · Tablet, orally disintegrating, delayed release · Capsule, delayed release pellets · Tablet, orally disintegrating |
|---|---|
| Route | Oral |
| Prescription products | 81 in the FDA NDC Directory |
| Brand names | Prevacid Solutab, Prevacid |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| lansoprazole 15 mg capsule, delayed release | Generic | $0.1445 per capsule |
| lansoprazole 15 mg capsule, delayed release pellets | Generic | $0.1445 per capsule |
| lansoprazole 15 mg tablet, orally disintegrating | Generic | $1.96 per tablet |
| lansoprazole 15 mg tablet, orally disintegrating, delayed release | Generic | $1.96 per tablet |
| lansoprazole 15 mg tablet, orally disintegrating, delayed release | Brand: Prevacid SoluTab | $13.25 per tablet |
| lansoprazole 30 mg capsule, delayed release | Generic | $0.1045 per capsule |
| lansoprazole 30 mg capsule, delayed release | Brand: Prevacid | $13.20 per capsule |
| lansoprazole 30 mg capsule, delayed release pellets | Generic | $0.1045 per capsule |
| lansoprazole 30 mg tablet, orally disintegrating | Generic | $2.35 per tablet |
| lansoprazole 30 mg tablet, orally disintegrating, delayed release | Generic | $2.35 per tablet |
| lansoprazole 30 mg tablet, orally disintegrating, delayed release | Brand: Prevacid SoluTab | $13.21 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack10 products
- NuCare Pharmaceuticals, Inc.10 products
- A-S Medication Solutions5 products
- Mylan Pharmaceuticals Inc.4 products
- Preferred Pharmaceuticals Inc.4 products
- Teva Pharmaceuticals USA, Inc.4 products
- Takeda Pharmaceuticals America, Inc.3 products
- Lifestar Pharma LLC2 products
- Zydus Lifesciences Limited2 products
- Aurobindo Pharma Limited2 products
- Cardinal Health 107, LLC2 products
- American Health Packaging2 products
- Xiromed, LLC2 products
- NorthStar Rx LLC2 products
- Camber Pharmaceuticals, Inc.2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Proficient Rx LP2 products
- BluePoint Laboratories2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Macleods Pharmaceuticals Limited2 products
- Dr.Reddy's Laboratories Ltd.2 products
- Ascend Laboratories, LLC2 products
- Ajanta Pharma USA Inc.2 products
- Redpharm Drug1 product
- Major Pharmaceuticals1 product
- Direct_Rx1 product
- Golden State Medical Supply, Inc.1 product
- Medcore LLC1 product
- Mylan Institutional Inc.1 product
- Quallent Pharmaceuticals Health LLC1 product
- Asclemed USA, Inc.1 product
- Safecor Health LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020406 PREVACID | Takeda Pharms USA | May 10, 1995 | 72, latest August 8, 2023 2023: Labeling · 2022: Labeling · 2020: Labeling |
| NDA021428 PREVACID | Takeda Pharms USA | August 30, 2002 | 26, latest August 8, 2023 2023: Labeling · 2022: Labeling · 2020: Labeling |
Generic approvals (14)
- ANDA077255Teva Pharms · November 10, 2009
- ANDA090763Mylan Pharms Inc · November 10, 2009
- ANDA091269DR Reddys Labs Ltd · October 15, 2010
- ANDA201921Natco Pharma Ltd · December 18, 2012
- ANDA203203Xiromed · July 25, 2016
- ANDA203957Ajanta Pharma Ltd · October 14, 2016
- ANDA205868Adaptis · August 30, 2017
- ANDA208784Teva Pharms USA · September 21, 2017
- ANDA200816Zydus Pharms · November 27, 2018
- ANDA202396Mylan · November 28, 2018
- ANDA207394Alkem Labs Ltd · January 18, 2019
- ANDA203083Hetero Labs Ltd III · May 18, 2020
- ANDA207167Aurobindo Pharma Ltd · March 28, 2023
- ANDA208671Macleods Pharms · November 4, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 23, 2022 · Class II · Terminated · D-0737-2022
Failed Dissolution Specifications; during long term stability testing.
Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India — Dr. Reddy's Laboratories, Inc.
-
March 23, 2022 · Class II · Terminated · D-0738-2022
Failed Dissolution Specifications; during long term stability testing.
Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90. — Dr. Reddy's Laboratories, Inc.
-
December 3, 2020 · Class II · Terminated · D-0146-2021
Failed Dissolution Specifications
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA — Zydus Pharmaceuticals (USA) Inc
-
December 3, 2020 · Class II · Terminated · D-0145-2021
Failed Dissolution Specifications
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA In — Zydus Pharmaceuticals (USA) Inc
-
October 27, 2020 · Class II · Terminated · D-0074-2021
Failed Dissolution Specification
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pen — Zydus Pharmaceuticals (USA) Inc
-
October 27, 2020 · Class II · Terminated · D-0075-2021
Failed Dissolution Specification
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pen — Zydus Pharmaceuticals (USA) Inc
-
March 11, 2019 · Class III · Terminated · D-1006-2019
Subpotent Drug.
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufact — Teva Pharmaceuticals USA
-
January 30, 2013 · Class II · Terminated · D-147-2013
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05. — Mylan Pharmaceuticals Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Prevacid, Takeda Pharmaceuticals America, Inc., effective July 8, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →