Amoxicillin
- Product NDC
- 55700-075
- Requested package NDC
- 55700-075-60
- 11-digit product format
- 557000075
- Labeler code
- 55700
- Product ID
- 55700-075_a8dfcf5c-edfd-4eef-a72d-9ef904f6f327
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA065291
- Marketing category
- ANDA
- Marketing start
- 2018-02-02
- Marketing end
- 2021-10-31
- Substance
- AMOXICILLIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
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 | 55700-075 | 55700-075-60 | D | Discontinued by firm | 2026-08-17 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065291-001 | AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | |
| A065291-002 | AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065291-001 | AB |
| A065291-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065291-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2007-02-05 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065291-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2007-02-05 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A065291-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A065291-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065291-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065291-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065291-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065291-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065291-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065291-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065291-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065291-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065291-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065291-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065291-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065291-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065291-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065291-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065291-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065291-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065291-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065291-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065291-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065291-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065291-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065291-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065291-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065291-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065291-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065291-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065291-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065291-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065291-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065291-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065291-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065291-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065291-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065291-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065291-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065291-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065291-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065291-002 | AB | 1 | bb7c543d1eb4… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-075-20 | EA - Each | 55700-075 | f7c573ab-e75e-4ec8-9fa0-38b15c66b11c | 1 | 2018-03-08 |
| 55700-075-21 | EA - Each | 55700-075 | cde213cc-dc97-42b9-81d8-75cd5ed72311 | 1 | 2019-01-24 |
| 55700-075-30 | EA - Each | 55700-075 | 7bbee32d-f756-467e-aab2-a7de00ac0983 | 1 | 2018-05-09 |
| 55700-075-60 | EA - Each | 55700-075 | 81c87157-78bc-4efc-ac54-4088cc929400 | 1 | 2018-03-08 |
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 | PD-Rx Pharmaceuticals, Inc. | 18a4f555-a537-4c40-9bb2-dc3bd782fa27 | 2026-07-17 | Warnings, Adverse reactions | 065291 ANDA065291 |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 96057ce7-9516-4239-9974-5e9691b44c9b | 2026-07-09 | Warnings, Adverse reactions | 065291 ANDA065291 |
| Amoxicillin | AMOXICILLIN | Hikma Pharmaceuticals USA Inc. | 4fb7837e-964c-4d38-a3a5-b384b1bd6e08 | 2026-03-01 | Warnings, Adverse reactions | 065291 ANDA065291 |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 039d2677-b04f-436c-e063-6294a90ac519 | 2025-10-20 | Warnings, Adverse reactions | 065291 ANDA065291 |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | b6ea2f81-aee6-4c88-b681-50eb28e80a86 | 2025-10-01 | Warnings, Adverse reactions | 065291 ANDA065291 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | fd071263-b750-4831-9fc5-de112a5f685b | 2025-06-27 | Warnings, Adverse reactions | 065291 ANDA065291 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | b988349d-2198-4dbb-a231-9ba37262ce28 | 2025-06-23 | Warnings, Adverse reactions | 065291 ANDA065291 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 364f969d-3037-4dff-b04b-304bca27442e | 2025-06-23 | Warnings, Adverse reactions | 065291 ANDA065291 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 521f7a05-4e6d-447f-b38e-00c4d623703b | 2025-06-23 | Warnings, Adverse reactions | 065291 ANDA065291 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-075-60 | 55700007560 | 60 CAPSULE in 1 BOTTLE, PLASTIC (55700-075-60) | 60 capsule | 2018-02-02 | 2021-10-31 | No | No | Current |