AMOXICILLIN AND CLAVULANATE POTASSIUM
- Product NDC
- 70518-3967
- 11-digit product format
- 705183967
- Labeler code
- 70518
- Product ID
- 70518-3967_54a0a3ed-70af-9018-e063-6294a90a1181
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA204755
- Marketing category
- ANDA
- Marketing start
- 2023-12-19
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 875; 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
- 2027-12-31
- 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 |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70518-3967 | 70518-3967-0 | D | Discontinued by firm | 2026-10-05 |
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 | 70518-3967-0 | 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 | 70518-3967-0 | 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 | 70518-3967-0 | 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 | 70518-3967-0 | 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 | 70518-3967-0 | 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 | 70518-3967-0 | 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 | 70518-3967-0 | 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 | 70518-3967-0 | 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 | 70518-3967-0 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204755-003 | 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 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A204755-003 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2016-12-30 | 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 | A204755-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204755-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204755-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204755-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204755-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204755-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204755-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204755-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204755-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204755-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204755-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204755-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204755-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204755-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204755-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A204755-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204755-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A204755-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A204755-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A204755-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A204755-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A204755-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204755-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A204755-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A204755-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A204755-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A204755-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A204755-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A204755-003 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204755-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A204755-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A204755-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204755-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204755-003 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204755-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204755-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A204755-003 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A204755-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204755-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A204755-003 | AB | 1 | f41ea6bd6efb… |
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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMOXICILLIN | 875 mg/1 |
| CLAVULANATE POTASSIUM | 125 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 804826J2HU | Internal UNII lookup |
| Q42OMW3AT8 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 562508 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e153a542-3a3c-48ff-84cf-970832d4e847 | 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 |
|---|---|---|---|---|---|---|
| 70518-3967-0 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 28 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 28 | 7 | |
| 70518-3967-1 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | 7 |
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 | REMEDYREPACK INC. | a26f2ceb-bb9b-4813-9691-634338186860 | 2026-08-31 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | 7526a33a-18d6-36ca-e053-2a91aa0ab9f9 | 2026-08-26 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | fbd40fcd-bf5b-e91e-e053-6394a90a609c | 2026-08-12 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | REMEDYREPACK INC. | e153a542-3a3c-48ff-84cf-970832d4e847 | 2026-06-19 | Warnings, Adverse reactions | 204755 ANDA204755 70518-3967 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Northwind Health Company, LLC | 1069b873-9bf9-cb22-e063-6394a90a4feb | 2026-06-18 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Micro Labs Limited | 0c2d1fbc-f80c-4737-a15e-9cfa6bf99769 | 2026-06-09 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | e08c1bee-14c8-4bd1-898c-1874251dadf8 | 2026-06-01 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Sportpharm LLC | 3f9beabd-b579-460a-8ceb-789389b109f8 | 2026-02-20 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Preferred Pharmaceuticals Inc. | da5bfc31-5431-49b4-b21b-619712ab43a7 | 2026-01-13 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | 6285c4f2-c13b-49a9-e053-2991aa0a2b03 | 2025-11-20 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Bryant Ranch Prepack | eef98beb-57d9-448a-b89c-6acd6f7b443e | 2025-10-23 | Warnings, Adverse reactions | 204755 ANDA204755 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Advanced Rx Pharmacy of Tennessee, LLC | d294e4a2-8ce7-418d-e053-2a95a90ab10b | 2025-02-02 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Bryant Ranch Prepack | 9bd9e662-0b80-45a8-906b-3dc04ee6b3ba | 2024-12-16 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Medsource Pharmaceuticals | 12a00e7e-80f5-7c5e-e063-6394a90a68d2 | 2024-03-01 | Warnings, Adverse reactions | 204755 ANDA204755 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Asclemed USA, Inc. | bf29327f-4e43-4597-83d2-f64349bf9d9a | 2020-09-01 | Warnings, Adverse reactions | 204755 ANDA204755 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | e153a542-3a3c-48ff-84cf-970832d4e847 | 7 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | e153a542-3a3c-48ff-84cf-970832d4e847 | 7 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | e153a542-3a3c-48ff-84cf-970832d4e847 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-3967-0 | 70518396700 | 28 in 1 BOTTLE, PLASTIC | Historical | ||||
| 70518-3967-1 | 70518396701 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3967-1) | 2026-02-06 | No | No | Current | |
| 70518-3967-2 | 70518396702 | 50 POUCH in 1 BOX (70518-3967-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-3967-3) | 50 pouch | 2026-06-19 | No | No | Current |