Sumatriptan
- Product NDC
- 0093-2013
- Requested package NDC
- 0093-2013-99
- 11-digit product format
- 000932013
- Labeler code
- 0093
- Product ID
- 0093-2013_c70368a4-4b28-4d08-aff9-85f4106834ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sumatriptan succinate
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Teva Pharmaceuticals USA Inc
- Application
- ANDA078319
- Marketing category
- ANDA
- Marketing start
- 2016-06-01
- Marketing end
- 0000-00-00
- Substance
- SUMATRIPTAN SUCCINATE
- Active strength
- 4 mg/.5mL
- 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
- 2023-12-31
- 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 |
|---|---|---|---|---|---|---|---|
| unfinished package | package | 0093-2013 | 0093-2013-99 | UNFINISHED | Active or certified unfinished drug listing | 2026-09-08 |
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 21:27 UTC · source 2025-12-05 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | 906f6e251498… | bf70b80e44f0… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078319-001 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | ||
| A078319-002 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 |
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 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | 2015-12-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AB | 2015-12-10 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AB | 2015-12-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AB | 2015-12-10 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AB | 2015-12-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AB | 2015-12-10 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AB | 2015-12-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AB | 2015-12-10 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AB | 2015-12-10 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078319-001 | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AB | 2015-12-10 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078319-002 | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AB | 2015-12-10 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078319-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078319-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078319-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078319-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078319-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078319-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078319-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078319-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078319-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078319-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078319-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078319-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078319-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078319-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078319-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A078319-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A078319-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A078319-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A078319-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078319-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A078319-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A078319-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A078319-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A078319-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A078319-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078319-002 | AB | 1 | ea99ee380514… |
| 2023-12-20 04:57 UTC | 2023-12 | A078319-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A078319-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078319-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078319-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078319-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078319-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078319-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078319-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078319-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078319-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A078319-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078319-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A078319-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078319-002 | AB | 1 | 3bdfa0b2c4d7… |
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SUMATRIPTAN SUCCINATE | 4 mg/.5mL |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Status |
|---|---|---|---|---|---|
| 0093-2013-99 | 00093201399 | 2400 SYRINGE in 1 BOX (0093-2013-99) / .5 mL in 1 SYRINGE | 2400 syringe | 24-MAR-22 | Current |