Amoxicillin and Clavulanate Potassium
- Product NDC
- 65862-501
- 11-digit product format
- 658620501
- Labeler code
- 65862
- Product ID
- 65862-501_2b91e9f8-c77e-4330-8fc1-e574758f0db6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA091569
- Marketing category
- ANDA
- Marketing start
- 2012-01-20
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 250; 125 mg/1; mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase 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 |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 65862-501 | UNFINISHED | Active or certified unfinished drug listing | 2026-09-14 | ||
| unfinished package | package | 65862-501 | 65862-501-15 | UNFINISHED | Active or certified unfinished drug listing | 2026-09-14 |
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65862-501-15 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65862-501-15 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65862-501-15 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65862-501-15 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65862-501-15 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65862-501-15 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65862-501-15 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65862-501-15 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 65862-501-15 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 65862-501-15 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 65862-501-15 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 65862-501-15 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 65862-501-15 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 65862-501-15 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished product | product | 906f6e251498… | bf70b80e44f0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 65862-501-15 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished product | product | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 65862-501-15 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished product | product | 8fc7167e32ce… | e96bbc724034… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 65862-501-15 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | 4184dd79f89f… | 545327b3e20f… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 65862-501-15 | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished product | product | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 65862-501-15 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 65862-501-15 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | 5b2001dcd8f5… | 54b53d4dc9e4… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 65862-501-15 | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | |
| A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2012-01-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091569-001 | AB |
| A091569-002 | 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 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2012-01-20 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2012-01-20 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2012-01-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2012-01-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2012-01-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2012-01-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2012-01-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2012-01-20 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2012-01-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2012-01-20 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091569-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091569-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091569-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091569-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091569-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091569-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091569-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091569-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091569-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091569-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091569-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091569-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091569-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091569-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091569-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091569-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091569-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091569-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091569-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091569-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091569-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091569-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091569-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091569-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091569-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091569-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091569-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091569-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091569-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091569-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091569-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091569-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091569-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091569-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091569-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091569-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091569-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091569-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091569-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091569-002 | AB | 1 | 74a2ff9319b5… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin and Clavulanate Potassium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMOXICILLIN | 250 mg/1 |
| CLAVULANATE POTASSIUM | 125 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| Q42OMW3AT8 | Internal UNII lookup |
| 804826J2HU | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ffb158a1-83ba-4100-9221-175aa986dc3e | 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 |
| 2ebbc361-d28f-48a9-a286-c1ae09cdaf5c | Product name | 3 | 20230314 |
| 2bb254ff-3d7f-4bdb-abf9-476506008c55 | Product name | 1 | 20230117 |
| 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 |
| ebb3e917-326a-9e18-0354-a19c9f63a2f3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-501-05 | Amoxicillin and Clavulanate Potassium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 23 | |
| 65862-501-30 | Amoxicillin and Clavulanate Potassium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 23 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-501-30 | EA - Each | 65862-501 | 9b620431-09b1-4d01-8b4c-36917b905dfd | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | 92ff1408-512c-d68d-e053-2a95a90adfbd | 2026-06-18 | Warnings, Adverse reactions | 091569 ANDA091569 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Sportpharm LLC | fabeca32-3f26-4b65-b8b6-5f0e23765ab0 | 2026-04-24 | Warnings, Adverse reactions | 091569 ANDA091569 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | American Health Packaging | 4966a3f2-eed2-4081-ba88-310a3d1964b4 | 2026-03-06 | Warnings, Adverse reactions | 091569 ANDA091569 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Preferred Pharmaceuticals Inc. | d23b6952-5e4c-4103-9fe0-a916b1e2e1b9 | 2026-03-03 | Warnings, Adverse reactions | 091569 ANDA091569 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Sportpharm LLC | 94b7c1bb-c024-4dc6-86d4-18a17a3eafcb | 2026-02-04 | Warnings, Adverse reactions | 091569 ANDA091569 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | 48356a07-60b9-c844-e063-6394a90afafa | 2026-01-12 | Warnings, Adverse reactions | 091569 ANDA091569 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | f433611c-db72-af7f-e053-2995a90a4a70 | 2026-01-05 | Warnings, Adverse reactions | 091569 ANDA091569 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | ef2c7783-e419-288f-e053-2a95a90a628a | 2025-12-11 | Warnings, Adverse reactions | 091569 ANDA091569 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | PD-Rx Pharmaceuticals, Inc. | b509d0eb-fe01-4902-89ae-a0dc7f7c7f93 | 2025-11-20 | Warnings, Adverse reactions | 091569 ANDA091569 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NorthStar Rx LLC | d75b0a7e-cb9b-4102-bcac-097403b25129 | 2025-09-12 | Warnings, Adverse reactions | 091569 ANDA091569 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Aurobindo Pharma Limited | ffb158a1-83ba-4100-9221-175aa986dc3e | 2025-07-01 | Warnings, Adverse reactions | 091569 ANDA091569 65862-501 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | af4c2ea8-73bd-429b-8392-fa20fec6fb3f | 2025-06-18 | Warnings, Adverse reactions | 091569 ANDA091569 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | 46921419-9fae-4f51-b1b2-dc2e1ab04e8e | 2024-06-28 | Warnings, Adverse reactions | 091569 ANDA091569 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 562251 | amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet | PSN | ffb158a1-83ba-4100-9221-175aa986dc3e | 23 |
| 617296 | amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet | PSN | ffb158a1-83ba-4100-9221-175aa986dc3e | 23 |
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | ffb158a1-83ba-4100-9221-175aa986dc3e | 23 |
| 562251 | amoxicillin 250 MG / clavulanate 125 MG Oral Tablet | SCD | ffb158a1-83ba-4100-9221-175aa986dc3e | 23 |
| 617296 | amoxicillin 500 MG / clavulanate 125 MG Oral Tablet | SCD | ffb158a1-83ba-4100-9221-175aa986dc3e | 23 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | ffb158a1-83ba-4100-9221-175aa986dc3e | 23 |
| 562251 | amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | ffb158a1-83ba-4100-9221-175aa986dc3e | 23 |
| 617296 | amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | ffb158a1-83ba-4100-9221-175aa986dc3e | 23 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | ffb158a1-83ba-4100-9221-175aa986dc3e | 23 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65862-501-05 | 65862050105 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-501-05) | 2012-01-20 | 0000-00-00 | No | No | Current |
| 65862-501-15 | 65862050115 | 1500 TABLET, FILM COATED in 1 BAG (65862-501-15) | 20-JAN-12 | Current | |||
| 65862-501-30 | 65862050130 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-501-30) | 2012-01-20 | 0000-00-00 | No | No | Current |