Amoxicillin and Clavulanate Potassium
- Product NDC
- 65862-535
- 11-digit product format
- 658620535
- Labeler code
- 65862
- Product ID
- 65862-535_3d50990e-9d7e-4a23-a135-97d5612ec0bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA201091
- Marketing category
- ANDA
- Marketing start
- 2011-12-20
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 600; 42.9 mg/5mL; mg/5mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201091-001 | 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 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 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 | A201091-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A201091-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A201091-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201091-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201091-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201091-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201091-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201091-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201091-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201091-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201091-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A201091-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201091-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201091-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201091-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A201091-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201091-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A201091-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A201091-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A201091-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A201091-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A201091-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201091-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A201091-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A201091-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A201091-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A201091-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A201091-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A201091-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201091-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A201091-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A201091-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201091-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201091-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201091-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201091-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A201091-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A201091-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201091-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A201091-001 | AB | 1 | f41ea6bd6efb… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin and Clavulanate Potassium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMOXICILLIN | 600 mg/5mL |
| CLAVULANATE POTASSIUM | 42.9 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 804826J2HU | Internal UNII lookup |
| Q42OMW3AT8 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 617993 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5200ae31-8a79-45f9-84fc-98f8448483a7 | 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 |
|---|---|---|---|---|---|---|
| 65862-535-02 | Amoxicillin and Clavulanate Potassium | 200 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 200 | 15 | |
| 65862-535-13 | Amoxicillin and Clavulanate Potassium | 125 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 125 | 15 | |
| 65862-535-75 | Amoxicillin and Clavulanate Potassium | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-535-02 | ML - Milliliter | 65862-535 | 147baf52-d412-4dc9-97c5-af638eab6b2a | 1 | 2012-07-24 |
| 65862-535-13 | ML - Milliliter | 65862-535 | eca6d1cd-6ee2-4919-ac4f-59d813457c26 | 1 | 2012-07-24 |
| 65862-535-75 | ML - Milliliter | 65862-535 | 2fb1e45e-c1c8-4cdd-8609-24163ef0ff90 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 | Redpharm Drug | 5250085e-5509-c577-e063-6294a90a9b87 | 2026-05-21 | Warnings, Adverse reactions | 201091 ANDA201091 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Preferred Pharmaceuticals, Inc. | 22a387bd-92ce-4ebc-b475-20d7750a2507 | 2026-03-04 | Warnings, Adverse reactions | 201091 ANDA201091 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | bcd19a89-e9dc-b85f-e053-2a95a90a6f3e | 2026-02-19 | Warnings, Adverse reactions | 201091 ANDA201091 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | 2a376d67-0bf2-43a1-8ca3-73f90689c339 | 2026-02-06 | Warnings, Adverse reactions | 201091 ANDA201091 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | ebf49514-0bce-ac56-e053-2a95a90ae540 | 2025-12-22 | Warnings, Adverse reactions | 201091 ANDA201091 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | ccb8bfb1-1303-4c2d-9106-78684e6b859f | 2025-12-19 | Warnings, Adverse reactions | 201091 ANDA201091 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NorthStar Rx LLC | df4136c0-9efd-42c3-a487-e728e8b91275 | 2025-04-03 | Warnings, Adverse reactions | 201091 ANDA201091 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Aurobindo Pharma Limited | 5200ae31-8a79-45f9-84fc-98f8448483a7 | 2025-02-11 | Warnings, Adverse reactions | 201091 ANDA201091 65862-535 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | 9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd | 2025-01-02 | Warnings, Adverse reactions | 201091 ANDA201091 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | a0ff848d-230a-ab6b-e053-2a95a90a8bb8 | 2024-06-20 | Warnings, Adverse reactions | 201091 ANDA201091 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | e05caabb-b95c-4e54-890e-bbc371a20fc3 | 2023-10-01 | Warnings, Adverse reactions | 201091 ANDA201091 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | bb75eb89-2579-4189-8dd2-40ae8727fe7c | 2022-03-01 | Warnings, Adverse reactions | 201091 ANDA201091 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension | PSN | 5200ae31-8a79-45f9-84fc-98f8448483a7 | 15 |
| 617993 | amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension | SCD | 5200ae31-8a79-45f9-84fc-98f8448483a7 | 15 |
| 617993 | amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension | SY | 5200ae31-8a79-45f9-84fc-98f8448483a7 | 15 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension | SY | 5200ae31-8a79-45f9-84fc-98f8448483a7 | 15 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension | PSN | 22a387bd-92ce-4ebc-b475-20d7750a2507 | 13 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension | PSN | 2a376d67-0bf2-43a1-8ca3-73f90689c339 | 13 |
| 617993 | amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension | SCD | 22a387bd-92ce-4ebc-b475-20d7750a2507 | 13 |
| 617993 | amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension | SCD | 2a376d67-0bf2-43a1-8ca3-73f90689c339 | 13 |
| 617993 | amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension | SY | 2a376d67-0bf2-43a1-8ca3-73f90689c339 | 13 |
| 617993 | amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension | SY | 22a387bd-92ce-4ebc-b475-20d7750a2507 | 13 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension | SY | 2a376d67-0bf2-43a1-8ca3-73f90689c339 | 13 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension | SY | 22a387bd-92ce-4ebc-b475-20d7750a2507 | 13 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension | PSN | bb75eb89-2579-4189-8dd2-40ae8727fe7c | 6 |
| 617993 | amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension | SCD | bb75eb89-2579-4189-8dd2-40ae8727fe7c | 6 |
| 617993 | amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension | SY | bb75eb89-2579-4189-8dd2-40ae8727fe7c | 6 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension | SY | bb75eb89-2579-4189-8dd2-40ae8727fe7c | 6 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension | PSN | 476ea419-8d88-40f0-a329-960e5e3859c6 | 4 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension | PSN | 9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd | 4 |
| 617993 | amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension | SCD | 476ea419-8d88-40f0-a329-960e5e3859c6 | 4 |
| 617993 | amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension | SCD | 9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd | 4 |
| 617993 | amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension | SY | 9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd | 4 |
| 617993 | amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension | SY | 476ea419-8d88-40f0-a329-960e5e3859c6 | 4 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension | SY | 9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd | 4 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension | SY | 476ea419-8d88-40f0-a329-960e5e3859c6 | 4 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension | PSN | a0ff848d-230a-ab6b-e053-2a95a90a8bb8 | 3 |
| 617993 | amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension | SCD | a0ff848d-230a-ab6b-e053-2a95a90a8bb8 | 3 |
| 617993 | amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension | SY | a0ff848d-230a-ab6b-e053-2a95a90a8bb8 | 3 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension | SY | a0ff848d-230a-ab6b-e053-2a95a90a8bb8 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-535-02 | 65862053502 | 200 mL in 1 BOTTLE (65862-535-02) | 200 ml | 2011-12-20 | 0000-00-00 | No | No | Current |
| 65862-535-13 | 65862053513 | 125 mL in 1 BOTTLE (65862-535-13) | 125 ml | 2011-12-20 | 0000-00-00 | No | No | Current |
| 65862-535-75 | 65862053575 | 75 mL in 1 BOTTLE (65862-535-75) | 75 ml | 2011-12-20 | 0000-00-00 | No | No | Current |