Amoxicillin
- Product NDC
- 68071-4944
- 11-digit product format
- 680714944
- Labeler code
- 68071
- Product ID
- 68071-4944_1b2e2026-ae73-e31c-e063-6294a90ab36d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA061926
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Substance
- AMOXICILLIN
- Active strength
- 250 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68071-4944-3 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68071-4944-3 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68071-4944-3 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 68071-4944-3 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 68071-4944-3 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 68071-4944-3 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 68071-4944-3 | 8dfbde2a14a4… | c9ff85d89658… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | |
| 2019-12-13 00:20 UTC | 2019-12 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A061926-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | Approved before 1982 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A061926-003 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | RS, Approved before 1982 | 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 | A061926-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A061926-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A061926-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A061926-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061926-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061926-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A061926-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A061926-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061926-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061926-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061926-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061926-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061926-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061926-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061926-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061926-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061926-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061926-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061926-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061926-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A061926-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A061926-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061926-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061926-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061926-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061926-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061926-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061926-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A061926-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A061926-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061926-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061926-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A061926-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A061926-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A061926-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A061926-003 | AB | 1 | 4b0b4de00fa7… |
| 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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMOXICILLIN | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 804826J2HU | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 308182 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8c3ba9cf-9a28-3965-e053-2a95a90a38ce | 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 |
| 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 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
| cf3f1c02-1f32-2322-3314-b70ebbf5610e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-4944-3 | Amoxicillin | 3 in 1 BOTTLE | CAPSULE | 3 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-4944 | AMOXICILLIN CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240619_8c3ba9cf-9a28-3965-e053-2a95a90a38ce.zip |
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 | Chartwell Governmental & Specialty RX, LLC | 809393b7-6271-4715-ae84-13fd8f901772 | 2026-07-30 | Warnings, Adverse reactions | 061926 ANDA061926 |
| AMOXICILLIN | AMOXICILLIN | Chartwell RX, LLC | b07b5ac4-253e-4c83-91c3-3fdc46e91a0f | 2026-07-24 | Warnings, Adverse reactions | 061926 ANDA061926 |
| 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 68071-4944 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | 8c3ba9cf-9a28-3965-e053-2a95a90a38ce | 2 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | 8c3ba9cf-9a28-3965-e053-2a95a90a38ce | 2 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | 8c3ba9cf-9a28-3965-e053-2a95a90a38ce | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-4944-3 | 68071494403 | 3 CAPSULE in 1 BOTTLE (68071-4944-3) | 3 capsule | 2019-06-26 | No | No | Current |