Amoxicillin
- Product NDC
- 50090-0288
- Requested package NDC
- 50090-0288-5
- 11-digit product format
- 500900288
- Labeler code
- 50090
- Product ID
- 50090-0288_c2556ec7-aa40-43b4-823e-397cc974540a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA065271
- Marketing category
- ANDA
- Marketing start
- 2005-11-09
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 250 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 package | package | 50090-0288 | 50090-0288-5 | 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 | 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… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065271-001 | AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | |
| A065271-002 | AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065271-001 | AB |
| A065271-002 | 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 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / 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 | A065271-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065271-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065271-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065271-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065271-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065271-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065271-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065271-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065271-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065271-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065271-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065271-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065271-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065271-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065271-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065271-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065271-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065271-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065271-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065271-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065271-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065271-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065271-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065271-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065271-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065271-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065271-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065271-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065271-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065271-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065271-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065271-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065271-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065271-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065271-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065271-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065271-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065271-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065271-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065271-002 | AB | 1 | 782e0a99824c… |
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0288-0 | EA - Each | 50090-0288 | cb39cff8-098d-4aee-8790-2606c49b21b9 | 1 | 2021-08-05 |
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 | NuCare Pharmaceuticals, Inc. | 4a402dba-c255-5db8-e054-00144ff8d46c | 2026-07-24 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8cb987bf-d45a-c15a-e053-2995a90aad46 | 2026-07-21 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | HAWAII REPACK, INC. | bf130964-8386-4ab7-8d3b-fb0174670afc | 2026-07-17 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Northwind Health Company, LLC | 1d0d8bc4-137e-ef10-e063-6294a90acf62 | 2026-07-09 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 53548597-347b-42a9-916c-e88cd27b8dcd | 2026-07-01 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 3a4afd36-dffa-44a1-9d09-e93cf66053bf | 2026-06-09 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | ef03286b-4ba7-4952-9ab1-90cacf300504 | 2026-06-01 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 5155ca5d-fe58-42b4-e063-6394a90ab135 | 2026-05-21 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 5020950a-b248-a463-e063-6294a90ae57f | 2026-04-23 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | afb4149a-0714-4a85-b9e8-2379a8e6a302 | 2026-04-08 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Sportpharm LLC | 9bb2856b-feef-4063-befc-2dd917502898 | 2026-03-20 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Preferred Phamraceuticals Inc. | 47424822-14a1-48e0-a62d-df34fe685726 | 2026-03-04 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | d6a33b28-f520-4a4c-b553-0ebd00558345 | 2026-03-03 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 800f5fac-f2af-358f-e053-2a91aa0ad6a6 | 2026-02-10 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Sportpharm LLC | d55dd9d9-e901-47b6-b496-5f2749726a2e | 2026-02-03 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin 500 mg | AMOXICILLIN | Health Department, Oklahoma State | f049551b-4708-eb13-e053-2a95a90afd1f | 2025-12-13 | 065271 ANDA065271 | |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | 32b224c2-1354-4b58-b082-b93330e6962b | 2025-12-10 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | QPharma Inc | 2772a745-1276-405b-b229-95edf5534b2a | 2025-12-05 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 071086f5-e4ed-b1d9-e063-6294a90ad304 | 2025-11-13 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | bbaeb509-ad04-4668-a1db-4358038893f2 | 2025-10-23 | Warnings, Adverse reactions | 065271 ANDA065271 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-0288-5 | 50090028805 | 15 CAPSULE in 1 BOTTLE (50090-0288-5) | 15 capsule | 2016-06-29 | 0000-00-00 | No | No | Current |