Lansoprazole
- Product NDC
- 11822-0019
- Requested package NDC
- 11822-0019-3
- 11-digit product format
- 118220019
- Labeler code
- 11822
- Product ID
- 11822-0019_29bc0c52-cb89-c360-5d22-11c168b6b1ea
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- ANDA202194
- Marketing category
- ANDA
- Marketing start
- 2022-10-01
- Substance
- LANSOPRAZOLE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 11822-0019 | 11822-0019-3 | I | Inactivated by FDA | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202194-001 | LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202194-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2012-05-18 | cb3db0bc1861… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d6b97638-59f4-48e2-8959-569628732c46 | Product name | 9 | 20210622 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-0019 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION] | 4 | Current NDC, Legacy NDC | 20241203_9f424ff5-671b-ccaf-0682-929a27feb548.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lansoprazole | LANSOPRAZOLE | Dr. Reddy's Laboratories Inc. | 4a701c0d-fef5-aa12-01e6-e3680a161a7d | 2026-07-21 | Warnings | 202194 ANDA202194 |
| Lansoprazole | LANSOPRAZOLE | Rugby Laboratories, Inc | aa95216c-8985-d160-1743-ba168a35177f | 2026-07-17 | Warnings | 202194 ANDA202194 |
| Lansoprazole | LANSOPRAZOLE | Dr. Reddy's Laboratories Inc. | a24acc0b-7770-1087-77bd-048259a5bf72 | 2026-07-15 | Warnings | 202194 ANDA202194 |
| Lansoprazole | LANSOPRAZOLE | LEADER/ Cardinal Health 110, Inc. | 486838cd-17ee-c2df-4e05-aa6106dd8fd8 | 2026-07-15 | Warnings | 202194 ANDA202194 |
| Lansoprazole | LANSOPRAZOLE | Dr. Reddy's Laboratories Limited | 15e05eda-48aa-a4b7-4b8a-4ee1cf110120 | 2026-07-09 | Warnings | 202194 ANDA202194 |
| Lansoprazole | LANSOPRAZOLE | AMERISOURCEBERGEN DRUG CORPORATION | accb92e8-dd14-b87b-c20a-6c4803815bc2 | 2026-04-17 | Warnings | 202194 ANDA202194 |
| Lansoprazole | LANSOPRAZOLE | Chain Drug Marketing Association | 74417c65-cccd-5a6a-0f96-0d8cb5a1592a | 2025-07-18 | Warnings | 202194 ANDA202194 |
| Lansoprazole | LANSOPRAZOLE | Walgreens company | 277093d5-cd0f-36ad-63d4-824a62d2a16c | 2025-07-18 | Warnings | 202194 ANDA202194 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 596843 | lansoprazole 15 MG Delayed Release Oral Capsule | PSN | 9f424ff5-671b-ccaf-0682-929a27feb548 | 5 |
| 596843 | lansoprazole 15 MG Delayed Release Oral Capsule | SCD | 9f424ff5-671b-ccaf-0682-929a27feb548 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11822-0019-3 | 11822001903 | 3 BOTTLE in 1 CARTON (11822-0019-3) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2022-10-01 | 0000-00-00 | No | No | Current |