Amoxicillin and Clavulanate Potassium
- Product NDC
- 85766-022
- 11-digit product format
- 857660022
- Labeler code
- 85766
- Product ID
- 85766-022_4a022ff2-b0e8-9063-e063-6294a90a8fbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- ANDA091569
- Marketing category
- ANDA
- Marketing start
- 2012-01-20
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 500; 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
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091569-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091569-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET / ORAL | AB | 2012-01-20 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2022-03-09 01:35 UTC | 2022-03 | A091569-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091569-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091569-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091569-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin and Clavulanate Potassium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMOXICILLIN | 500 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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 94b7c1bb-c024-4dc6-86d4-18a17a3eafcb | 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 |
|---|---|---|---|---|---|---|
| 85766-022-20 | Amoxicillin and Clavulanate Potassium | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 3 |
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 85766-022 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617296 | amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet | PSN | 94b7c1bb-c024-4dc6-86d4-18a17a3eafcb | 3 |
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | 94b7c1bb-c024-4dc6-86d4-18a17a3eafcb | 3 |
| 617296 | amoxicillin 500 MG / clavulanate 125 MG Oral Tablet | SCD | 94b7c1bb-c024-4dc6-86d4-18a17a3eafcb | 3 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | 94b7c1bb-c024-4dc6-86d4-18a17a3eafcb | 3 |
| 617296 | amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | 94b7c1bb-c024-4dc6-86d4-18a17a3eafcb | 3 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | 94b7c1bb-c024-4dc6-86d4-18a17a3eafcb | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 85766-022-20 | 85766002220 | 20 TABLET, FILM COATED in 1 BOTTLE (85766-022-20) | 2025-08-13 | No | No | Current |