Lansoprazole
- Product NDC
- 11822-3374
- 11-digit product format
- 118223374
- Labeler code
- 11822
- Product ID
- 11822-3374_a4c3b92d-38c5-4375-a950-42bf3af2482d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- ANDA203187
- Marketing category
- ANDA
- Marketing start
- 2019-11-29
- Marketing end
- 2026-11-29
- 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
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 11822-3374-5 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 11822-3374-7 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 11822-3374-5 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 11822-3374-7 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 11822-3374-5 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 11822-3374-7 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 11822-3374-5 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 11822-3374-7 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 11822-3374-7 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 11822-3374-5 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 11822-3374-7 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 11822-3374-5 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 11822-3374-7 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 11822-3374-5 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203187-001 | LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 |
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 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203187-001 | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2016-06-01 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lansoprazole
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LANSOPRAZOLE | 15 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0K5C5T2QPG | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 596843 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5f256a0c-14df-4fd9-a818-b4276954152e | Available on FDA.report |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 11822-3374-5 | 2025-08-25 | DRUG FACTS |
| 11822-3374-7 | 2025-08-25 | DRUG FACTS |
| 11822-3374-5 | 2025-01-30 | DRUG FACTS |
| 11822-3374-7 | 2025-01-30 | DRUG FACTS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-3374-5 | Lansoprazole | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 4 | |
| 11822-3374-5 | Lansoprazole | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | 4 | |
| 11822-3374-7 | Lansoprazole | 3 in 1 BOX | CAPSULE, DELAYED RELEASE | 3 | 4 | |
| 11822-3374-7 | Lansoprazole | 14 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 14 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-3374 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION] | 3 | Current NDC, Legacy NDC, 4 package rows | 20220513_5f256a0c-14df-4fd9-a818-b4276954152e.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 | Rite Aid Corporation | 5f256a0c-14df-4fd9-a818-b4276954152e | 2025-08-25 | Warnings | 203187 ANDA203187 11822-3374 |
| Lansoprazole | LANSOPRAZOLE | CVS Pharmacy | d52b26e2-3d2a-4067-a28b-8697f865f582 | 2025-08-20 | Warnings | 203187 ANDA203187 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 596843 | lansoprazole 15 MG Delayed Release Oral Capsule | PSN | 5f256a0c-14df-4fd9-a818-b4276954152e | 4 |
| 596843 | lansoprazole 15 MG Delayed Release Oral Capsule | SCD | 5f256a0c-14df-4fd9-a818-b4276954152e | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11822-3374-5 | 11822337405 | 1 BOTTLE in 1 CARTON (11822-3374-5) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2019-11-29 | 2026-11-29 | No | No | Current |
| 11822-3374-7 | 11822337407 | 3 BOTTLE, PLASTIC in 1 BOX (11822-3374-7) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2019-11-29 | 2026-11-29 | No | No | Current |