Amoxicillin and Clavulanate Potassium
- Product NDC
- 59115-025
- 11-digit product format
- 591150025
- Labeler code
- 59115
- Product ID
- 59115-025_a7cc798a-bf65-4460-ab3c-9503905afb36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceutical
- Application
- ANDA203824
- Marketing category
- ANDA
- Marketing start
- 2016-08-23
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 875 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203824-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203824-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-08-23 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203824-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203824-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203824-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203824-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203824-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203824-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203824-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203824-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203824-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203824-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203824-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203824-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203824-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203824-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203824-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203824-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203824-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203824-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A203824-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203824-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203824-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A203824-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A203824-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A203824-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A203824-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A203824-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A203824-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203824-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A203824-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A203824-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203824-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203824-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203824-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203824-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A203824-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A203824-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203824-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A203824-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A203824-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203824-001 | AB | 1 | cb3db0bc1861… |
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 | PD-Rx Pharmaceuticals, Inc. | d213685c-5e67-4130-b00b-7626685dfa16 | 2026-02-26 | Warnings, Adverse reactions | 203824 ANDA203824 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 6a078e7d-f942-4185-a131-50215d8e0a1e | 2026-02-25 | Warnings, Adverse reactions | 203824 ANDA203824 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | PD-Rx Pharmaceuticals, Inc. | f229e8b4-7045-4c0d-9214-890c0bda3c2a | 2026-02-16 | Warnings, Adverse reactions | 203824 ANDA203824 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | a3d1c0bb-94f3-4cfb-a4c6-233cf7e519a4 | 2026-02-13 | Warnings, Adverse reactions | 203824 ANDA203824 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | 8dba4e86-5f79-0bea-e053-2a95a90a9e2d | 2025-12-15 | Warnings, Adverse reactions | 203824 ANDA203824 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | 9015d3dc-1ab4-2582-e053-2995a90a1679 | 2025-10-07 | Warnings, Adverse reactions | 203824 ANDA203824 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | REMEDYREPACK INC. | e5b0770d-1301-498e-a4ed-41874d7bf225 | 2025-09-26 | Warnings, Adverse reactions | 203824 ANDA203824 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Hikma Pharmaceuticals USA Inc. | 52ab3500-d088-4693-acea-9b83c0843f66 | 2025-08-01 | Warnings, Adverse reactions | 203824 ANDA203824 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | b0d7eb3e-706a-482b-b106-9c137be55bb6 | 2025-04-01 | Warnings, Adverse reactions | 203824 ANDA203824 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | 67b8567a-bab7-4859-88d6-c2ea695b9f0a | 2024-10-30 | Warnings, Adverse reactions | 203824 ANDA203824 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | 9263495c-310a-c20e-e053-2995a90a2e87 | 2024-06-19 | Warnings, Adverse reactions | 203824 ANDA203824 |