Amoxicillin
- Product NDC
- 55289-020
- 11-digit product format
- 552890020
- Labeler code
- 55289
- Product ID
- 55289-020_e6e997ff-d352-79a0-e053-2a95a90a1ba7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA061926
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 product | product | 55289-020 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 55289-020 | 55289-020-04 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-06 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-09 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-14 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-15 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-21 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-24 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-28 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-30 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-40 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-42 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-50 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-56 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-60 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 55289-020 | 55289-020-63 | D | Discontinued by firm | 2026-10-15 |
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.
| Dataset | Scope | Package NDC |
|---|---|---|
| excluded product | product | |
| excluded package | package | 55289-020-50 |
| excluded package | package | 55289-020-15 |
| excluded package | package | 55289-020-04 |
| excluded package | package | 55289-020-28 |
| excluded package | package | 55289-020-24 |
| excluded package | package | 55289-020-30 |
| excluded package | package | 55289-020-14 |
| excluded package | package | 55289-020-42 |
| excluded package | package | 55289-020-56 |
| excluded package | package | 55289-020-21 |
| excluded package | package | 55289-020-60 |
| excluded package | package | 55289-020-09 |
| excluded package | package | 55289-020-06 |
| excluded package | package | 55289-020-63 |
| excluded package | package | 55289-020-40 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A061926-001 | AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | |
| A061926-003 | AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A061926-001 | AB |
| A061926-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A061926-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A061926-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A061926-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A061926-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A061926-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A061926-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A061926-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A061926-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A061926-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A061926-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A061926-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A061926-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A061926-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A061926-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A061926-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A061926-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A061926-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A061926-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A061926-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A061926-003 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A061926-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A061926-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A061926-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A061926-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A061926-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A061926-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A061926-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A061926-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A061926-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A061926-003 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A061926-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A061926-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A061926-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A061926-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A061926-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A061926-003 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A061926-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A061926-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A061926-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A061926-003 | AB | 1 | 3a93d1ddd44b… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
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 | AMOXICILLIN | QPharma, Inc | 60c788d1-6c91-4456-848a-893e649e90be | 2026-05-08 | Warnings, Adverse reactions | 061926 ANDA061926 |
| Amoxicillin | AMOXICILLIN | Redpharm Drug | 3d0025b4-b7bb-69db-e063-6294a90a0e70 | 2025-08-23 | Warnings, Adverse reactions | 061926 ANDA061926 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 80a04b8a-110e-0aea-e053-2a91aa0ad057 | 2025-02-06 | Warnings, Adverse reactions | 061926 ANDA061926 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8c3ba9cf-9a28-3965-e053-2a95a90a38ce | 2024-06-18 | Warnings, Adverse reactions | 061926 ANDA061926 |
| Amoxicillin | AMOXICILLIN | Teva Pharmaceuticals USA, Inc. | 4c0f348a-a65d-409c-8668-207c82a5e3cb | 2024-05-22 | Warnings, Adverse reactions | 061926 ANDA061926 |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | be1d1a44-7ef3-445d-9970-494921de4c9d | 2023-03-18 | Warnings, Adverse reactions | 061926 ANDA061926 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55289-020-04 | 55289002004 | 4 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-04) | 4 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-06 | 55289002006 | 6 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-06) | 6 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-09 | 55289002009 | 9 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-09) | 9 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-14 | 55289002014 | 14 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-14) | 14 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-15 | 55289002015 | 15 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-15) | 15 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-21 | 55289002021 | 21 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-21) | 21 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-24 | 55289002024 | 24 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-24) | 24 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-28 | 55289002028 | 28 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-28) | 28 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-30 | 55289002030 | 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-30) | 30 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-40 | 55289002040 | 40 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-40) | 40 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-42 | 55289002042 | 42 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-42) | 42 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-50 | 55289002050 | 50 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-50) | 50 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-56 | 55289002056 | 56 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-56) | 56 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-60 | 55289002060 | 60 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-60) | 60 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |
| 55289-020-63 | 55289002063 | 63 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-63) | 63 capsule | 2013-03-25 | 0000-00-00 | No | No | Current |