Amoxicillan and clavulanate potassium
- Product NDC
- 51655-158
- 11-digit product format
- 516550158
- Labeler code
- 51655
- Product ID
- 51655-158_c07e72b4-3106-4cd3-acd8-365121c5e687
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillan and clavulanate potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Pharmaceuticals, LLC
- Application
- ANDA091569
- Marketing category
- ANDA
- Marketing start
- 2014-07-18
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 500 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 product | product | 51655-158 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 51655-158 | 51655-158-03 | D | Discontinued by firm | 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 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51655-158-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 51655-158-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 51655-158-03 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 51655-158-03 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 51655-158-03 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 51655-158-03 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 51655-158-03 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 51655-158-03 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 51655-158-03 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 51655-158-03 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 51655-158-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 51655-158-03 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 51655-158-03 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 51655-158-03 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 51655-158-03 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 51655-158-03 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 51655-158-03 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 51655-158-03 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 51655-158-03 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 51655-158-03 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 51655-158-03 | 9bebd1f3094a… | 5416666fcb17… |
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.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51655-158-03 | 2026-01-02 | C162847 | 48780-1 | 9d75b9d1-233a-f424-e053-dadaa90a57ce | AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated |
| 51655-158-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-233a-f424-e053-dadaa90a57ce | AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLAN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 1 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLAN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 1 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLAN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 1 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | AMOXICILLAN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 1 |
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 |
| 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 |