Amoxicillin
- Product NDC
- 65862-015
- 11-digit product format
- 658620015
- Labeler code
- 65862
- Product ID
- 65862-015_ee0e12cd-e881-4048-a0fb-74bd771cb9aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA065256
- Marketing category
- ANDA
- Marketing start
- 2005-11-09
- Substance
- AMOXICILLIN
- Active strength
- 875 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 65862-015 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-12 | ||
| unfinished package | package | 65862-015 | 65862-015-89 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-12 | |
| unfinished package | package | 65862-015 | 65862-015-99 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-12 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65862-015-99 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65862-015-89 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65862-015-99 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65862-015-89 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65862-015-99 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65862-015-89 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65862-015-99 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65862-015-89 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65862-015-99 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65862-015-89 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65862-015-99 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65862-015-89 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65862-015-99 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65862-015-89 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65862-015-99 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65862-015-89 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 65862-015-99 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 65862-015-89 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 65862-015-99 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 65862-015-89 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 65862-015-99 | 27f29a85d7e4… | 1372111e901f… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 65862-015-89 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 65862-015-99 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 65862-015-89 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 65862-015-99 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 65862-015-89 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 65862-015-99 | 50b4072663b7… | eae3003ed65e… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 65862-015-89 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished product | product | 906f6e251498… | bf70b80e44f0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 65862-015-89 | 906f6e251498… | bf70b80e44f0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 65862-015-99 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished product | product | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 65862-015-89 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 65862-015-99 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished product | product | 8fc7167e32ce… | e96bbc724034… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 65862-015-89 | 8fc7167e32ce… | e96bbc724034… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 65862-015-99 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | 4184dd79f89f… | 545327b3e20f… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 65862-015-99 | 4184dd79f89f… | 545327b3e20f… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 65862-015-89 | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished product | product | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 65862-015-99 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 65862-015-89 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 65862-015-99 | 263afe128892… | 91768de4ddbe… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 65862-015-89 | 263afe128892… | 91768de4ddbe… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065256-001 | AMOXICILLIN | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | |
| A065256-002 | AMOXICILLIN | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065256-001 | AB |
| A065256-002 | 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 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 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 | A065256-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065256-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065256-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065256-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065256-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065256-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065256-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065256-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065256-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065256-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065256-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065256-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065256-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065256-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065256-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065256-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065256-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065256-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065256-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065256-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065256-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065256-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065256-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065256-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065256-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065256-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065256-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065256-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065256-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065256-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065256-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065256-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065256-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065256-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065256-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065256-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065256-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065256-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065256-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065256-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMOXICILLIN | 875 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 804826J2HU | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e | 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 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| cf3f1c02-1f32-2322-3314-b70ebbf5610e | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-015-01 | Amoxicillin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 17 | |
| 65862-015-05 | Amoxicillin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 17 | |
| 65862-015-20 | Amoxicillin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-015-01 | EA - Each | 65862-015 | db23ecaa-6809-4e97-bcfb-9dc3c742b76c | 1 | 2012-07-24 |
| 65862-015-05 | EA - Each | 65862-015 | 9b386731-410c-4274-8a2a-66c42428d187 | 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 | AMOXICILLIN | Coupler LLC | 5827b6de-6b48-d73a-e063-6394a90a4a72 | 2026-08-03 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | a2c91cf0-a4e4-44c0-b712-bee63dd6c22b | 2026-07-22 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 9618d038-e880-47f6-b8d7-bbf8ab35364d | 2026-07-21 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | f37eb415-77b2-41b0-8d20-64e821e4b05d | 2026-06-10 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 313ea909-5b1b-41ff-a0db-5aadc12e2e4f | 2026-06-01 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 5037e2a5-52e9-caec-e063-6294a90ad837 | 2026-04-28 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | American Health Packaging | d339ea0f-8797-460f-a3b7-b8455c250366 | 2026-04-07 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | 4b23e6f5-9287-4c01-b795-b8c538833039 | 2026-03-04 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | f1eee459-9021-b26e-e053-2995a90a7291 | 2026-02-18 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | QPharma, Inc. | 2700df91-c5ef-4931-9ad7-a3c1c146ccac | 2025-12-09 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8e6f9df1-0754-69e4-e053-2a95a90acc49 | 2025-12-02 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 3e4f0f03-438b-ddfb-e063-6294a90adb38 | 2025-09-08 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 3880b9c2-62a5-0d23-e063-6394a90a1252 | 2025-06-26 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | b91f40dd-40db-473d-a399-166aeb1ce7e2 | 2025-05-15 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | aaf42367-153e-4525-af5f-f5f1c7d6c559 | 2024-12-24 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | bef50f2a-78c6-4d0c-8ad9-cfa3c801629d | 2024-11-25 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 963986fc-0e59-21b0-e053-2a95a90a9531 | 2024-10-10 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | c3d3f94f-e976-4625-9667-3d716932f2fa | 2024-10-09 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 20eb4ade-f3b8-db66-e063-6294a90ae846 | 2024-08-30 | Warnings, Adverse reactions | 065256 ANDA065256 |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | a18751fa-6202-4ae2-950a-a3f1dc9a8afd | 2024-08-21 | Warnings, Adverse reactions | 065256 ANDA065256 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308192 | amoxicillin 500 MG Oral Tablet | PSN | c3d3f94f-e976-4625-9667-3d716932f2fa | 29 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | c3d3f94f-e976-4625-9667-3d716932f2fa | 29 |
| 308192 | amoxicillin 500 MG Oral Tablet | SCD | c3d3f94f-e976-4625-9667-3d716932f2fa | 29 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | c3d3f94f-e976-4625-9667-3d716932f2fa | 29 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | c3d3f94f-e976-4625-9667-3d716932f2fa | 29 |
| 308192 | amoxicillin 500 MG Oral Tablet | PSN | 99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e | 17 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e | 17 |
| 308192 | amoxicillin 500 MG Oral Tablet | SCD | 99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e | 17 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e | 17 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e | 17 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 9618d038-e880-47f6-b8d7-bbf8ab35364d | 16 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 9618d038-e880-47f6-b8d7-bbf8ab35364d | 16 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 9618d038-e880-47f6-b8d7-bbf8ab35364d | 16 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 00fbd46e-05fd-4f8a-9f59-a7a4d01c8e54 | 14 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 00fbd46e-05fd-4f8a-9f59-a7a4d01c8e54 | 14 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 00fbd46e-05fd-4f8a-9f59-a7a4d01c8e54 | 14 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 2700df91-c5ef-4931-9ad7-a3c1c146ccac | 7 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 2700df91-c5ef-4931-9ad7-a3c1c146ccac | 7 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 2700df91-c5ef-4931-9ad7-a3c1c146ccac | 7 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 586a5911-e30b-40ed-a056-9e67920ca951 | 3 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 586a5911-e30b-40ed-a056-9e67920ca951 | 3 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 586a5911-e30b-40ed-a056-9e67920ca951 | 3 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 31c12a11-7bce-4457-b413-feaad0da9c49 | 2 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 271ddc63-b31b-2f46-e054-00144ff8d46c | 2 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 7a15d4c8-d214-446a-8d24-8b2defdf8e02 | 2 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 5037e2a5-52e9-caec-e063-6294a90ad837 | 2 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 5037e2a5-52e9-caec-e063-6294a90ad837 | 2 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 7a15d4c8-d214-446a-8d24-8b2defdf8e02 | 2 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 271ddc63-b31b-2f46-e054-00144ff8d46c | 2 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 31c12a11-7bce-4457-b413-feaad0da9c49 | 2 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 31c12a11-7bce-4457-b413-feaad0da9c49 | 2 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 5037e2a5-52e9-caec-e063-6294a90ad837 | 2 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 271ddc63-b31b-2f46-e054-00144ff8d46c | 2 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 7a15d4c8-d214-446a-8d24-8b2defdf8e02 | 2 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | bc4ce768-a615-4458-9d60-baeada6886cd | 1 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 6b577898-b36a-425c-8cf3-36230347b2d2 | 1 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 9179bb1b-8554-4c00-a323-aac951ae2f55 | 1 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 9179bb1b-8554-4c00-a323-aac951ae2f55 | 1 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | bc4ce768-a615-4458-9d60-baeada6886cd | 1 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 6b577898-b36a-425c-8cf3-36230347b2d2 | 1 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | bc4ce768-a615-4458-9d60-baeada6886cd | 1 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 9179bb1b-8554-4c00-a323-aac951ae2f55 | 1 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 6b577898-b36a-425c-8cf3-36230347b2d2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65862-015-01 | 65862001501 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-015-01) | 2005-11-09 | 0000-00-00 | No | No | Current |
| 65862-015-05 | 65862001505 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-015-05) | 2005-11-09 | 0000-00-00 | No | No | Current |
| 65862-015-20 | 65862001520 | 20 TABLET, FILM COATED in 1 BOTTLE (65862-015-20) | 2005-11-09 | 0000-00-00 | No | No | Current |
| 65862-015-89 | 65862001589 | 900 TABLET, FILM COATED in 1 BAG (65862-015-89) | 09-NOV-05 | Current | |||
| 65862-015-99 | 65862001599 | 1000 TABLET, FILM COATED in 1 BAG (65862-015-99) | 09-NOV-05 | Current |