Amoxicillin and Clavulanate Potassium
- Product NDC
- 70518-3624
- 11-digit product format
- 705183624
- Labeler code
- 70518
- Product ID
- 70518-3624_59041c0c-0b1d-0c99-e063-6294a90a7d76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA065063
- Marketing category
- ANDA
- Marketing start
- 2023-01-27
- 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 | 70518-3624 | 70518-3624-0 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 70518-3624 | 70518-3624-3 | 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 package | package | 70518-3624-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-3624-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-3624-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-3624-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-3624-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-3624-0 | 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 | 70518-3624-0 | 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 | 70518-3624-0 | 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 | 70518-3624-0 | 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 | 70518-3624-0 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065063-001 | 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 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A065063-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | RS | 2002-03-14 | 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 | A065063-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A065063-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065063-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065063-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065063-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065063-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065063-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065063-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065063-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065063-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065063-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065063-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065063-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065063-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065063-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065063-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065063-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065063-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065063-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065063-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065063-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065063-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065063-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A065063-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A065063-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A065063-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A065063-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A065063-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065063-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065063-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A065063-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A065063-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065063-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065063-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065063-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065063-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A065063-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A065063-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065063-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A065063-001 | 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 |
|---|---|
| c88b2b50-c664-43b3-9c37-f134a329dc21 | 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 |
|---|---|---|---|---|---|---|
| 70518-3624-0 | Amoxicillin and Clavulanate Potassium | 100 in 1 BOX | TABLET, FILM COATED | 100 | 8 | |
| 70518-3624-1 | Amoxicillin and Clavulanate Potassium | 1 in 1 POUCH | TABLET, FILM COATED | 1 | 8 | |
| 70518-3624-2 | Amoxicillin and Clavulanate Potassium | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 8 | |
| 70518-3624-3 | Amoxicillin and Clavulanate Potassium | 14 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 14 | 8 | |
| 70518-3624-4 | Amoxicillin and Clavulanate Potassium | 100 in 1 BOX | TABLET, FILM COATED | 100 | 8 | |
| 70518-3624-5 | Amoxicillin and Clavulanate Potassium | 1 in 1 POUCH | TABLET, FILM COATED | 1 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3624 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.] | 5 | Current NDC, 6 package rows | 20250316_c88b2b50-c664-43b3-9c37-f134a329dc21.zip |
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. | c88b2b50-c664-43b3-9c37-f134a329dc21 | 2026-08-14 | Warnings, Adverse reactions | 065063 ANDA065063 70518-3624 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals, Inc. | 377abca8-7076-9ad0-e063-6294a90aa5dc | 2025-06-13 | Warnings, Adverse reactions | 065063 ANDA065063 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals, Inc. | 348f7f77-ba7e-5dd9-e063-6294a90a0991 | 2025-05-07 | Warnings, Adverse reactions | 065063 ANDA065063 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Sandoz Inc | 7cba82f0-9886-46e9-8dbd-43a448aade29 | 2025-05-01 | Warnings, Adverse reactions | 065063 ANDA065063 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals, Inc. | 31d00820-1c20-d52b-e063-6394a90ac312 | 2025-04-02 | Warnings, Adverse reactions | 065063 ANDA065063 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | f9b4d263-bc5b-6065-e053-6394a90a5e35 | 2025-02-10 | Warnings, Adverse reactions | 065063 ANDA065063 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Asclemed USA, Inc. | a94cfba3-27ed-46a3-81ef-e9b80187c207 | 2024-06-13 | Warnings, Adverse reactions | 065063 ANDA065063 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Bryant Ranch Prepack | 917a76e9-eb2b-4d49-9418-ff919a73cfad | 2024-05-29 | Warnings, Adverse reactions | 065063 ANDA065063 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | a0d22635-0e11-448d-b151-6f6168c65723 | 2022-11-01 | Warnings, Adverse reactions | 065063 ANDA065063 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | 5b68b2bf-b581-4372-87be-a6394ee56961 | 2022-05-01 | Warnings, Adverse reactions | 065063 ANDA065063 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | f636413f-82e5-446f-94cc-b4841bdedb33 | 2022-04-01 | Warnings, Adverse reactions | 065063 ANDA065063 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | c88b2b50-c664-43b3-9c37-f134a329dc21 | 8 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | c88b2b50-c664-43b3-9c37-f134a329dc21 | 8 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | c88b2b50-c664-43b3-9c37-f134a329dc21 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-3624-0 | 70518362400 | 100 in 1 BOX | Historical | ||||
| 70518-3624-1 | 70518362401 | 1 in 1 POUCH | Historical | ||||
| 70518-3624-2 | 70518362402 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3624-2) | 2025-02-12 | No | No | Current | |
| 70518-3624-3 | 70518362403 | 14 in 1 BOTTLE, PLASTIC | Historical | ||||
| 70518-3624-4 | 70518362404 | 100 POUCH in 1 BOX (70518-3624-4) / 1 TABLET, FILM COATED in 1 POUCH (70518-3624-5) | 100 pouch | 2025-12-23 | No | No | Current |
| 70518-3624-5 | 70518362405 | 1 in 1 POUCH | Historical |