Lansoprazole, Amoxicillin, Clarithromycin
- Product NDC
- 57237-001
- Requested package NDC
- 57237-001-14
- 11-digit product format
- 572370001
- Labeler code
- 57237
- Product ID
- 57237-001_bca6d415-61f6-4758-91fc-964d1e40c81b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lansoprazole, Amoxicillin, Clarithromycin
- Dosage form
- KIT
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA206006
- Marketing category
- ANDA
- Marketing start
- 2016-10-14
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2022-04-09 23:13 UTC · source 2022-04-08 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206006-001 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG | CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL | AB | RS | 2016-10-07 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG | CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL | AB | RS | 2016-10-07 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG | CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL | AB | RS | 2016-10-07 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG | CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL | AB | RS | 2016-10-07 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG | CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL | AB | RS | 2016-10-07 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG | CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL | AB | RS | 2016-10-07 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG | CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL | AB | RS | 2016-10-07 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG | CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL | AB | RS | 2016-10-07 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A206006-001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2016-10-07 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206006-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A206006-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206006-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206006-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206006-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206006-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206006-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206006-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206006-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206006-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206006-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206006-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206006-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206006-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206006-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A206006-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206006-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A206006-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206006-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A206006-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A206006-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A206006-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206006-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206006-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A206006-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A206006-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A206006-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A206006-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206006-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206006-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A206006-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A206006-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206006-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206006-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206006-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206006-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A206006-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A206006-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206006-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A206006-001 | AB | 1 | f41ea6bd6efb… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lansoprazole, Amoxicillin, Clarithromycin
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 502415e5-4ac7-4266-a01a-ef44aa3c028d | Product name | 7 | 20250623 |
| d0f377c9-74d8-e2e3-e06e-4d37534f5c0f | Product name | 3 | 20250620 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 2ebbc361-d28f-48a9-a286-c1ae09cdaf5c | Product name | 3 | 20230314 |
| 2bb254ff-3d7f-4bdb-abf9-476506008c55 | Product name | 1 | 20230117 |
| e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2 | Product name | 7 | 20221114 |
| d6b97638-59f4-48e2-8959-569628732c46 | Product name | 9 | 20210622 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
| cf3f1c02-1f32-2322-3314-b70ebbf5610e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57237-001-14 | 2022-04-20 | C162847 | 48780-1 | 9d75b9d0-f016-f424-e053-dadaa90a57ce | Lansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg Rx only |
| 57237-001-14 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f016-f424-e053-dadaa90a57ce | Lansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-001-01 | Lansoprazole, Amoxicillin, Clarithromycin | 1 in 1 BLISTER PACK | KIT | 1 | 13 | |
| 57237-001-14 | Lansoprazole, Amoxicillin, Clarithromycin | 14 in 1 CARTON | KIT | 14 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-001-01 | EA - Each | 57237-001 | 01b6981f-89ce-49c1-917d-2a9c12aae7c1 | 1 | 2016-12-07 |
| 57237-001-14 | EA - Each | 57237-001 | fef45051-3218-445a-b742-a73b7e58fa0d | 1 | 2016-11-08 |
DailyMed Dashboard NDC Coverage#
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, Amoxicillin, Clarithromycin | LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN | Rising Pharma Holdings, Inc. | 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00 | 2025-02-19 | Warnings, Adverse reactions | 206006 ANDA206006 57237-001-14 57237-001 57237000114 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 757968 | {4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (lansoprazole 30 MG Delayed Release Oral Capsule) } Pack | GPCK | 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00 | 13 |
| 757968 | 4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (lansoprazole 30 MG Delayed Release Oral Capsule) Pack | PSN | 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00 | 13 |
| 308191 | amoxicillin 500 MG Oral Capsule | PSN | 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00 | 13 |
| 197517 | clarithromycin 500 MG Oral Tablet | PSN | 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00 | 13 |
| 311277 | lansoprazole 30 MG Delayed Release Oral Capsule | PSN | 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00 | 13 |
| 308191 | amoxicillin 500 MG Oral Capsule | SCD | 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00 | 13 |
| 197517 | clarithromycin 500 MG Oral Tablet | SCD | 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00 | 13 |
| 311277 | lansoprazole 30 MG Delayed Release Oral Capsule | SCD | 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00 | 13 |
| 308191 | amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule | SY | 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57237-001-14 | 57237000114 | 14 BLISTER PACK in 1 CARTON (57237-001-14) / 1 KIT in 1 BLISTER PACK (57237-001-01) | 14 blister pack | 2016-10-14 | 0000-00-00 | No | No | Current |