Sumatriptan
- Product NDC
- 80425-0475
- 11-digit product format
- 804250475
- Labeler code
- 80425
- Product ID
- 80425-0475_2aab828f-48fd-5ff9-e063-6394a90ac966
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sumatriptan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA078284
- Marketing category
- ANDA
- Marketing start
- 2024-12-30
- Substance
- SUMATRIPTAN SUCCINATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
- 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 |
|---|---|---|---|---|---|---|---|
| A078284-001 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | |
| A078284-002 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | |
| A078284-003 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078284-001 | AB |
| A078284-002 | AB |
| A078284-003 | 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 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078284-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078284-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078284-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078284-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078284-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078284-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078284-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078284-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078284-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078284-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078284-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078284-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078284-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078284-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078284-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078284-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078284-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078284-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078284-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078284-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078284-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078284-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078284-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078284-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078284-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078284-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078284-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078284-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078284-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078284-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078284-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078284-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078284-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078284-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078284-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078284-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078284-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078284-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078284-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078284-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078284-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078284-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078284-001 | AB | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sumatriptan
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SUMATRIPTAN SUCCINATE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| J8BDZ68989 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 313161 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2aab8786-b225-833a-e063-6394a90ac7ae | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0475-1 | Sumatriptan | 9 in 1 BLISTER PACK | TABLET, FILM COATED | 9 | 1 | |
| 80425-0475-1 | Sumatriptan | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0475-1 | EA - Each | 80425-0475 | fc6dda65-8bf6-41f1-a0e3-e4499582e1b5 | 1 | 2025-02-10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0475 | SUMATRIPTAN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 2 package rows | 20250103_2aab8786-b225-833a-e063-6394a90ac7ae.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 |
|---|---|---|---|---|---|---|
| Sumatriptan | SUMATRIPTAN | Bionpharma Inc. | e90b0eea-c424-4f00-98da-6ed6e80de1f6 | 2026-05-29 | Warnings, Adverse reactions | 078284 ANDA078284 |
| Sumatriptan | SUMATRIPTAN | Preferred Pharmaceuticals Inc. | 0b9a0ab5-d8bd-4cae-b86c-45740ee1015a | 2025-09-25 | Warnings, Adverse reactions | 078284 ANDA078284 |
| Sumatriptan | SUMATRIPTAN | Preferred Pharmaceuticals Inc. | ff08b9ee-03bf-4f5b-930e-233a3b8866af | 2025-09-25 | Warnings, Adverse reactions | 078284 ANDA078284 |
| Sumatriptan | SUMATRIPTAN | NuCare Pharmaceuticals,Inc. | 082d05f6-3850-0fa2-e063-6294a90a0c66 | 2025-02-03 | Warnings, Adverse reactions | 078284 ANDA078284 |
| Sumatriptan | SUMATRIPTAN | Direct_Rx | efb7ec4e-0a5d-2aae-e053-2a95a90aebf2 | 2025-01-22 | Warnings, Adverse reactions | 078284 ANDA078284 |
| Sumatriptan | SUMATRIPTAN | Proficient Rx LP | 85bf8e58-0984-427b-9ed4-7e0df4e444d2 | 2025-01-01 | Warnings, Adverse reactions | 078284 ANDA078284 |
| Sumatriptan | SUMATRIPTAN | Advanced Rx Pharmacy of Tennessee, LLC | f27ca3c0-9de0-ff9c-e053-2a95a90ab894 | 2024-12-31 | Warnings, Adverse reactions | 078284 ANDA078284 |
| Sumatriptan | SUMATRIPTAN | Advanced Rx of Tennessee, LLC | 2aab8786-b225-833a-e063-6394a90ac7ae | 2024-12-30 | Warnings, Adverse reactions | 078284 ANDA078284 80425-0475 |
| Sumatriptan Succinate | SUMATRIPTAN SUCCINATE | Direct_Rx | 284ee7ac-759e-b592-e063-6394a90a78ba | 2024-12-02 | Warnings, Adverse reactions | 078284 ANDA078284 |
| Sumatriptan | SUMATRIPTAN | A-S Medication Solutions | 790acc89-81b3-4869-92e7-dc9f7fa6567b | 2024-11-08 | Warnings, Adverse reactions | 078284 ANDA078284 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313161 | SUMAtriptan succinate 50 MG Oral Tablet | PSN | 2aab8786-b225-833a-e063-6394a90ac7ae | 1 |
| 313161 | sumatriptan 50 MG Oral Tablet | SCD | 2aab8786-b225-833a-e063-6394a90ac7ae | 1 |
| 313161 | sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral Tablet | SY | 2aab8786-b225-833a-e063-6394a90ac7ae | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80425-0475-1 | 80425047501 | 1 BLISTER PACK in 1 CARTON (80425-0475-1) / 9 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2024-12-30 | No | No | Current |