sumatriptan succinate
- Product NDC
- 68788-8205
- 11-digit product format
- 687888205
- Labeler code
- 68788
- Product ID
- 68788-8205_5de50f82-7b63-45f9-bf6c-8a3a731f1147
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sumatriptan succinate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078295
- Marketing category
- ANDA
- Marketing start
- 2022-05-27
- Marketing end
- 0000-00-00
- Substance
- SUMATRIPTAN SUCCINATE
- Active strength
- 25 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
- 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 |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68788-8205 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 68788-8205 | 68788-8205-9 | D | Discontinued by firm | 2026-08-17 |
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 68788-8205 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-8205 | 68788-8205-9 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078295-001 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | 2009-08-10 | ||
| A078295-002 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | 2009-08-10 | ||
| A078295-003 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | 2009-08-10 |
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 | A078295-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | 2009-08-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078295-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | 2009-08-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078295-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | 2009-08-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078295-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | 2009-08-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078295-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | 2009-08-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078295-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | 2009-08-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078295-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | 2009-08-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078295-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | 2009-08-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078295-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | 2009-08-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078295-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | 2009-08-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078295-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | 2009-08-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078295-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | 2009-08-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078295-001 | 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 | A078295-002 | 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 | A078295-003 | 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 | A078295-001 | 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 | A078295-002 | 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 | A078295-003 | 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 | A078295-001 | 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 | A078295-002 | 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 | A078295-003 | 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 | A078295-001 | 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 | A078295-002 | 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 | A078295-003 | 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 | A078295-001 | 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 | A078295-002 | 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 | A078295-003 | 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 | A078295-001 | 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 | A078295-002 | 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 | A078295-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078295-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078295-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078295-003 | 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 | A078295-001 | 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 | A078295-002 | 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 | A078295-003 | 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 | A078295-001 | 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 | A078295-002 | 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 | A078295-003 | 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 | A078295-001 | 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 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078295-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078295-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078295-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078295-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078295-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078295-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078295-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078295-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078295-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078295-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078295-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078295-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078295-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078295-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078295-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078295-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078295-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078295-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078295-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078295-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078295-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078295-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078295-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078295-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078295-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078295-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078295-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078295-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078295-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078295-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078295-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078295-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078295-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078295-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078295-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078295-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078295-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078295-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078295-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078295-001 | AB | 1 | 4b0b4de00fa7… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8205-9 | EA - Each | 68788-8205 | 30181390-7697-4761-a099-0253319544a3 | 1 | 2022-07-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8205 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 3 | Legacy NDC | 20240816_5de50f82-7b63-45f9-bf6c-8a3a731f1147.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 succinate | SUMATRIPTAN SUCCINATE | Sun Pharmaceutical Industries, Inc. | 9485cc30-15e8-4b53-876d-db317145474b | 2026-06-25 | Warnings, Adverse reactions | 078295 ANDA078295 |
| Sumatriptan Succinate | SUMATRIPTAN SUCCINATE | Direct_Rx | f6c95873-576d-a1c2-e053-6294a90a3ff9 | 2025-01-22 | Warnings, Adverse reactions | 078295 ANDA078295 |
| Sumatriptan Succinate | SUMATRIPTAN SUCCINATE | Direct_Rx | f6c907a3-9624-f893-e053-6294a90a31af | 2025-01-22 | Warnings, Adverse reactions | 078295 ANDA078295 |
| sumatriptan succinate | SUMATRIPTAN SUCCINATE | A-S Medication Solutions | 97016a59-3b49-4134-85aa-8c866f285601 | 2023-11-22 | Warnings, Adverse reactions | 078295 ANDA078295 |
| sumatriptan succinate | SUMATRIPTAN SUCCINATE | Proficient Rx LP | 9f4d487a-c5f7-4707-976b-64e738c98d45 | 2022-04-01 | Warnings, Adverse reactions | 078295 ANDA078295 |
| sumatriptan succinate | SUMATRIPTAN SUCCINATE | Proficient Rx LP | d556563f-ad71-45c1-829a-cc11983bce0c | 2020-03-01 | Warnings, Adverse reactions | 078295 ANDA078295 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-8205-9 | 68788820509 | 9 TABLET, FILM COATED in 1 BOTTLE (68788-8205-9) | 2022-05-27 | 0000-00-00 | No | No | Current |