Amoxicillin
- Product NDC
- 68788-6374
- 11-digit product format
- 687886374
- Labeler code
- 68788
- Product ID
- 68788-6374_a6d5efd2-2373-49ed-83ae-07e24d2c596e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA064076
- Marketing category
- ANDA
- Marketing start
- 2016-04-13
- 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 | 68788-6374 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 68788-6374 | 68788-6374-2 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-6374 | 68788-6374-3 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-6374 | 68788-6374-4 | D | Discontinued by firm | 2026-08-03 |
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 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-6374-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-6374-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-6374-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-6374-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-6374-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-6374-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-6374-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-6374-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-6374-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-6374-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-6374-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-6374-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-6374-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-6374-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-6374-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-6374-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-6374-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-6374-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-6374-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-6374-4 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-6374-2 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-6374-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-6374-4 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-6374-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-6374-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-6374-4 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-6374-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-6374-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-6374-4 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-6374-2 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064076-001 | AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | |
| A064076-002 | AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A064076-001 | AB |
| A064076-002 | 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 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | 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 | A064076-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A064076-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064076-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064076-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064076-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A064076-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064076-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064076-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064076-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064076-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064076-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064076-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064076-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064076-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064076-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064076-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064076-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064076-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064076-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A064076-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064076-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064076-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064076-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064076-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064076-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064076-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064076-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A064076-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064076-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064076-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064076-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A064076-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064076-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A064076-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064076-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A064076-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064076-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A064076-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064076-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A064076-002 | 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 | REMEDYREPACK INC. | 102c62ca-da20-4866-84a8-e3513824af4a | 2026-07-21 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Northwind Health Company, LLC | 4ecefd37-9847-1d93-e063-6394a90a19f0 | 2026-07-09 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 52bd03c6-528a-c443-e063-6394a90aad39 | 2026-05-26 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | be7d8459-b8e6-499a-ab87-99bd17492525 | 2026-05-08 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | QPharma Inc | ddd1307d-3216-0e59-e053-2995a90ad19d | 2026-05-08 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 50fff2b8-8bf1-ff46-e063-6394a90a9213 | 2026-05-04 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 82c0c5d1-df2d-4352-bd12-99f955af569e | 2026-02-17 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | bb95fd06-f200-4de3-bfae-84d642d8e0f3 | 2026-02-02 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 76ba0f8d-4d1c-a5ff-e053-2a91aa0a7555 | 2024-06-12 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 6e9bf369-2f96-c7ae-e053-2a91aa0a715f | 2024-06-10 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 7b182161-128e-430c-98b2-592c242ba711 | 2024-05-30 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 260a3a79-9dd6-4c4b-82ec-f8050346e886 | 2024-05-30 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | aee851cf-428e-4d29-a281-078fe00c56b0 | 2024-05-30 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 9925773d-8ea1-4193-91e3-52cc1ce5ca67 | 2024-05-30 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Sandoz Inc | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 2024-02-22 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | c5d39ce2-8ae4-4bba-893f-a713afba1893 | 2023-04-17 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | f27237d7-123a-44ba-97df-b2446a94e3e5 | 2021-11-24 | Warnings, Adverse reactions | 064076 ANDA064076 |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 9528a356-4101-4be2-a7e2-b0659e169e1a | 2021-01-01 | Warnings, Adverse reactions | 064076 ANDA064076 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68788-6374-2 | 68788637402 | 21 CAPSULE in 1 BOTTLE (68788-6374-2) | 21 capsule | 2016-04-13 | 0000-00-00 | No | No | Current |
| 68788-6374-3 | 68788637403 | 30 CAPSULE in 1 BOTTLE (68788-6374-3) | 30 capsule | 2016-04-13 | 0000-00-00 | No | No | Current |
| 68788-6374-4 | 68788637404 | 40 CAPSULE in 1 BOTTLE (68788-6374-4) | 40 capsule | 2016-04-13 | 0000-00-00 | No | No | Current |