Amoxicillin
- Product NDC
- 55289-182
- 11-digit product format
- 552890182
- Labeler code
- 55289
- Product ID
- 55289-182_40d4dda4-d330-a59c-e063-6394a90acc36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA064013
- Marketing category
- ANDA
- Marketing start
- 1993-01-01
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064013-001 | AMOXICILLIN | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | |
| A064013-002 | AMOXICILLIN | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 |
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 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | RS | 1992-12-22 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 1995-09-11 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A064013-001 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | AB | RS | 1992-12-22 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A064013-002 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | AB | 1995-09-11 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-12-28 21:50 UTC | 2021-12 | A064013-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A064013-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064013-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064013-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064013-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A064013-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064013-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A064013-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064013-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A064013-002 | AB | 1 | c0c555d07b60… |
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 |
|---|---|
| 598025 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 98e9274c-c02e-44d9-8cc5-17536ef03a77 | 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 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| cf3f1c02-1f32-2322-3314-b70ebbf5610e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55289-182-06 | Amoxicillin | 6 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 6 | 24 | |
| 55289-182-09 | Amoxicillin | 9 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 9 | 24 | |
| 55289-182-14 | Amoxicillin | 14 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 14 | 24 | |
| 55289-182-20 | Amoxicillin | 20 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 20 | 24 | |
| 55289-182-30 | Amoxicillin | 30 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 30 | 24 | |
| 55289-182-40 | Amoxicillin | 40 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 40 | 24 | |
| 55289-182-90 | Amoxicillin | 90 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 90 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55289-182-06 | EA - Each | 55289-182 | 73dbf215-c41b-4906-9f27-fa30cebb9697 | 1 | 2012-07-24 |
| 55289-182-09 | EA - Each | 55289-182 | 38deb93a-1eb5-41a8-a624-9ba85f359b5e | 1 | 2012-07-24 |
| 55289-182-14 | EA - Each | 55289-182 | fd929266-d050-4d42-9987-92a38f1bb2ec | 1 | 2012-07-24 |
| 55289-182-20 | EA - Each | 55289-182 | 1c56723a-a60f-4232-a9d4-b1b3ec8e1614 | 1 | 2025-12-16 |
| 55289-182-30 | EA - Each | 55289-182 | 0e523918-80dc-43bd-8ef5-5162d1fd1ff9 | 1 | 2012-07-24 |
| 55289-182-40 | EA - Each | 55289-182 | a7bc6fe0-bb6e-4bf2-b502-dc1c99f7dd85 | 1 | 2012-07-24 |
| 55289-182-90 | EA - Each | 55289-182 | d9ad80e7-19c9-4eed-b525-51761870bd5e | 1 | 2016-09-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] | 5 |
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 | Chartwell RX, LLC | b07b5ac4-253e-4c83-91c3-3fdc46e91a0f | 2026-07-24 | Warnings, Adverse reactions | 064013 ANDA064013 |
| Amoxicillin | AMOXICILLIN | Northwind Health Company, LLC | 26e257d5-5b98-3795-e063-6394a90a05bc | 2026-07-09 | Warnings, Adverse reactions | 064013 ANDA064013 |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 98e9274c-c02e-44d9-8cc5-17536ef03a77 | 2025-10-10 | Warnings, Adverse reactions | 064013 ANDA064013 55289-182 |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd | 2025-07-17 | Warnings, Adverse reactions | 064013 ANDA064013 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 3d6cf1b3-f1dc-4eab-e054-00144ff88e88 | 2025-03-10 | Warnings, Adverse reactions | 064013 ANDA064013 |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 52e676e4-b70e-4e73-bbe7-f54d91ca7e0a | 2024-10-01 | Warnings, Adverse reactions | 064013 ANDA064013 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8c3dd74c-872a-1ba1-e053-2a95a90a7cb3 | 2024-06-13 | Warnings, Adverse reactions | 064013 ANDA064013 |
| Amoxicillin | AMOXICILLIN | Teva Pharmaceuticals USA, Inc. | 4c0f348a-a65d-409c-8668-207c82a5e3cb | 2024-05-22 | Warnings, Adverse reactions | 064013 ANDA064013 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 63b395ca-f0ea-4429-b8aa-18f495596e4d | 2024-04-29 | Warnings, Adverse reactions | 064013 ANDA064013 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 452eb254-028a-4e02-9cb0-85483a4abaf5 | 2024-02-13 | Warnings, Adverse reactions | 064013 ANDA064013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 598025 | amoxicillin 250 MG Chewable Tablet | PSN | 98e9274c-c02e-44d9-8cc5-17536ef03a77 | 24 |
| 598025 | amoxicillin 250 MG Chewable Tablet | SCD | 98e9274c-c02e-44d9-8cc5-17536ef03a77 | 24 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55289-182-06 | 55289018206 | 6 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-06) | 2015-10-12 | 0000-00-00 | No | No | Current |
| 55289-182-09 | 55289018209 | 9 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-09) | 2015-10-12 | 0000-00-00 | No | No | Current |
| 55289-182-14 | 55289018214 | 14 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-14) | 2015-10-12 | 0000-00-00 | No | No | Current |
| 55289-182-20 | 55289018220 | 20 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-20) | 2025-10-10 | No | No | Current | |
| 55289-182-30 | 55289018230 | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-30) | 2015-10-12 | 0000-00-00 | No | No | Current |
| 55289-182-40 | 55289018240 | 40 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-40) | 2015-10-12 | 0000-00-00 | No | No | Current |
| 55289-182-90 | 55289018290 | 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-182-90) | 2016-08-08 | 0000-00-00 | No | No | Current |