Amoxicillin
- Product NDC
- 0781-2020
- 11-digit product format
- 007812020
- Labeler code
- 0781
- Product ID
- 0781-2020_6aa02079-d11c-4d2f-acaf-9548dd9a7ed6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA064076
- Marketing category
- ANDA
- Marketing start
- 1994-09-30
- 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
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A064076-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 1994-09-30 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A064076-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 1994-09-30 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A064076-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A064076-002 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 0781-2020 |
| 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 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMOXICILLIN | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 804826J2HU | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 13bd4214-9b7f-425b-af5f-fc1ddc678230 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0781-2020-01 | Amoxicillin | 100 in 1 BOTTLE | CAPSULE | 100 | 25 | |
| 0781-2020-05 | Amoxicillin | 500 in 1 BOTTLE | CAPSULE | 500 | 25 | |
| 0781-2020-31 | Amoxicillin | 30 in 1 BOTTLE | CAPSULE | 30 | 25 | |
| 0781-2020-76 | Amoxicillin | 12 in 1 PACKAGE | CAPSULE | 12 | 25 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-2020-01 | EA - Each | 0781-2020 | c5b1f922-6f4f-4f7e-b3f3-5c57e974851d | 1 | 2012-07-24 |
| 0781-2020-05 | EA - Each | 0781-2020 | c6157bce-0265-4237-96e5-82b3f32c6362 | 1 | 2012-07-24 |
| 0781-2020-31 | EA - Each | 0781-2020 | ebada240-1cb7-430c-9baa-d49078e45f54 | 1 | 2012-07-24 |
| 0781-2020-76 | EA - Each | 0781-2020 | 1ac9abe5-f15b-4de3-96f2-d8cb0a109db6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | 7b182161-128e-430c-98b2-592c242ba711 | 102 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | 7b182161-128e-430c-98b2-592c242ba711 | 102 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | 7b182161-128e-430c-98b2-592c242ba711 | 102 |
| 313797 | amoxicillin 125 MG in 5 mL Oral Suspension | PSN | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 313850 | amoxicillin 200 MG in 5 mL Oral Suspension | PSN | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 239191 | amoxicillin 250 MG in 5 mL Oral Suspension | PSN | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308189 | amoxicillin 400 MG in 5 mL Oral Suspension | PSN | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308191 | amoxicillin 500 MG Oral Capsule | PSN | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308192 | amoxicillin 500 MG Oral Tablet | PSN | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 313797 | amoxicillin 25 MG/ML Oral Suspension | SCD | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 313850 | amoxicillin 40 MG/ML Oral Suspension | SCD | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 239191 | amoxicillin 50 MG/ML Oral Suspension | SCD | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308191 | amoxicillin 500 MG Oral Capsule | SCD | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308192 | amoxicillin 500 MG Oral Tablet | SCD | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308189 | amoxicillin 80 MG/ML Oral Suspension | SCD | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 313797 | amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral Suspension | SY | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 313850 | amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension | SY | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 239191 | amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension | SY | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308189 | amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension | SY | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308191 | amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule | SY | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 313797 | amoxicillin 125 MG per 5 ML Oral Suspension | SY | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 313850 | amoxicillin 200 MG per 5 ML Oral Suspension | SY | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 239191 | amoxicillin 250 MG per 5 ML Oral Suspension | SY | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 25 |
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | bb95fd06-f200-4de3-bfae-84d642d8e0f3 | 10 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | bb95fd06-f200-4de3-bfae-84d642d8e0f3 | 10 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | bb95fd06-f200-4de3-bfae-84d642d8e0f3 | 10 |
| 313797 | amoxicillin 125 MG in 5 mL Oral Suspension | PSN | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 313850 | amoxicillin 200 MG in 5 mL Oral Suspension | PSN | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 239191 | amoxicillin 250 MG in 5 mL Oral Suspension | PSN | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308189 | amoxicillin 400 MG in 5 mL Oral Suspension | PSN | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308191 | amoxicillin 500 MG Oral Capsule | PSN | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308194 | amoxicillin 875 MG Oral Tablet | PSN | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 313797 | amoxicillin 25 MG/ML Oral Suspension | SCD | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 313850 | amoxicillin 40 MG/ML Oral Suspension | SCD | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 239191 | amoxicillin 50 MG/ML Oral Suspension | SCD | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308191 | amoxicillin 500 MG Oral Capsule | SCD | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308189 | amoxicillin 80 MG/ML Oral Suspension | SCD | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308194 | amoxicillin 875 MG Oral Tablet | SCD | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 313797 | amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral Suspension | SY | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 313850 | amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension | SY | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 239191 | amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension | SY | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308189 | amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension | SY | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308191 | amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule | SY | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308194 | amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet | SY | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 313797 | amoxicillin 125 MG per 5 ML Oral Suspension | SY | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 313850 | amoxicillin 200 MG per 5 ML Oral Suspension | SY | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 239191 | amoxicillin 250 MG per 5 ML Oral Suspension | SY | daa89601-3e7c-4d9e-9bed-fd6abf20348e | 6 |
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | 9528a356-4101-4be2-a7e2-b0659e169e1a | 3 |
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | 737df78d-f8b3-260e-e053-2a91aa0a4d35 | 3 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | 737df78d-f8b3-260e-e053-2a91aa0a4d35 | 3 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | 9528a356-4101-4be2-a7e2-b0659e169e1a | 3 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | 737df78d-f8b3-260e-e053-2a91aa0a4d35 | 3 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | 9528a356-4101-4be2-a7e2-b0659e169e1a | 3 |
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | f1740cd4-d0f4-6f4b-e053-2995a90aa398 | 1 |
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | 2f27307c-27a9-4ec3-bccd-d0d13d86b185 | 1 |
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | 4ecefd37-9847-1d93-e063-6394a90a19f0 | 1 |
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | 50fff2b8-8bf1-ff46-e063-6394a90a9213 | 1 |
| 308191 | amoxicillin 500 MG Oral Capsule | PSN | 2f27307c-27a9-4ec3-bccd-d0d13d86b185 | 1 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | 4ecefd37-9847-1d93-e063-6394a90a19f0 | 1 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | 2f27307c-27a9-4ec3-bccd-d0d13d86b185 | 1 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | 50fff2b8-8bf1-ff46-e063-6394a90a9213 | 1 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | f1740cd4-d0f4-6f4b-e053-2995a90aa398 | 1 |
| 308191 | amoxicillin 500 MG Oral Capsule | SCD | 2f27307c-27a9-4ec3-bccd-d0d13d86b185 | 1 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | 50fff2b8-8bf1-ff46-e063-6394a90a9213 | 1 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | 4ecefd37-9847-1d93-e063-6394a90a19f0 | 1 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | 2f27307c-27a9-4ec3-bccd-d0d13d86b185 | 1 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | f1740cd4-d0f4-6f4b-e053-2995a90aa398 | 1 |
| 308191 | amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule | SY | 2f27307c-27a9-4ec3-bccd-d0d13d86b185 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0781-2020-01 | 00781202001 | 100 CAPSULE in 1 BOTTLE (0781-2020-01) | 100 capsule | 1994-09-30 | 0000-00-00 | No | No | Current |
| 0781-2020-05 | 00781202005 | 500 CAPSULE in 1 BOTTLE (0781-2020-05) | 500 capsule | 1994-09-30 | 0000-00-00 | No | No | Current |
| 0781-2020-31 | 00781202031 | 30 in 1 BOTTLE | Historical | |||||
| 0781-2020-76 | 00781202076 | 12 BOTTLE in 1 PACKAGE (0781-2020-76) / 30 CAPSULE in 1 BOTTLE (0781-2020-31) | 12 bottle | 1994-09-30 | 0000-00-00 | No | No | Current |