Amoxicillin
- Product NDC
- 59115-045
- 11-digit product format
- 591150045
- Labeler code
- 59115
- Product ID
- 59115-045_43603a64-325c-4c5a-b7c4-4b06d15b8c9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Hikma Pharmaceutical
- Application
- ANDA065325
- Marketing category
- ANDA
- Marketing start
- 2006-06-19
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 200 mg/5mL
- Pharmacologic classes
- Penicillin-clas
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|---|---|---|---|---|---|---|
| A065325-001 | AMOXICILLIN | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | |
| A065325-002 | AMOXICILLIN | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065325-001 | AB |
| A065325-002 | 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 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065325-001 | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065325-002 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 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 | A065325-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065325-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065325-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065325-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065325-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065325-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065325-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065325-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065325-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065325-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065325-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065325-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065325-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065325-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065325-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065325-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065325-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065325-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065325-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065325-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065325-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065325-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065325-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065325-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065325-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065325-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065325-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065325-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065325-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065325-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065325-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065325-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065325-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065325-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065325-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065325-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065325-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065325-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065325-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065325-002 | AB | 1 | 782e0a99824c… |
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 | AMOXICILLIN | Preferred Pharmaceuticals Inc. | afef7c71-2d19-41ed-9213-b32ccc1bf1d3 | 2026-03-04 | Warnings, Adverse reactions | 065325 ANDA065325 |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | c0e333d9-164d-4196-b5f5-929993d1c3c2 | 2026-03-04 | Warnings, Adverse reactions | 065325 ANDA065325 |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | 992d7829-34d1-4c88-8a5c-1a92d001d194 | 2025-03-24 | Warnings, Adverse reactions | 065325 ANDA065325 |
| Amoxil | AMOXICILLIN ORAL SUSP | DirectRx | ec7dd735-dc92-3d29-e053-2a95a90af549 | 2025-01-22 | Warnings, Adverse reactions | 065325 ANDA065325 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 59a546ed-84b7-a54a-e053-2991aa0a3a0d | 2024-12-26 | Warnings, Adverse reactions | 065325 ANDA065325 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8398f2c9-37ca-9b59-e053-2991aa0a2c11 | 2024-06-14 | Warnings, Adverse reactions | 065325 ANDA065325 |
| Amoxicillin | AMOXICILLIN | Hikma Pharmaceuticals USA Inc. | d46f1091-33dc-4f8f-9c34-75dcfedb4b4c | 2024-02-01 | Warnings, Adverse reactions | 065325 ANDA065325 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | cef5b1ae-8454-4e7a-8830-dd5d601c1d21 | 2023-12-09 | Warnings, Adverse reactions | 065325 ANDA065325 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 156ef8e9-b6e4-4512-865f-7139c90c8f9b | 2023-09-10 | Warnings, Adverse reactions | 065325 ANDA065325 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 77265bcd-c05d-443a-84c4-6e5ac75ee42c | 2023-02-21 | Warnings, Adverse reactions | 065325 ANDA065325 |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 756545f1-77af-49a0-a697-4cced31711d4 | 2022-06-01 | Warnings, Adverse reactions | 065325 ANDA065325 |