Sumatriptan
- Product NDC
- 50436-0147
- 11-digit product format
- 504360147
- Labeler code
- 50436
- Product ID
- 50436-0147_5c7f3427-8ed8-4155-8264-b05d746fff7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sumatriptan Succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA078327
- Marketing category
- ANDA
- Marketing start
- 2009-08-17
- Marketing end
- 0000-00-00
- Substance
- SUMATRIPTAN SUCCINATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 50436-0147 | I | Inactivated by FDA | 2026-08-11 | ||
| excluded package | package | 50436-0147 | 50436-0147-1 | I | Inactivated by FDA | 2026-08-11 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50436-0147-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50436-0147-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50436-0147-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50436-0147-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50436-0147-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50436-0147-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50436-0147-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50436-0147-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50436-0147-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50436-0147-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50436-0147-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50436-0147-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50436-0147-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50436-0147-1 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50436-0147-1 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 50436-0147-1 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 50436-0147-1 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 50436-0147-1 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 50436-0147-1 | 8dfbde2a14a4… | c9ff85d89658… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078327-001 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | |
| A078327-002 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | |
| A078327-003 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078327-001 | AB |
| A078327-002 | AB |
| A078327-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078327-003 | 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 | A078327-001 | 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 | A078327-002 | 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 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-003 | 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 | A078327-001 | 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 | A078327-002 | 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 | A078327-003 | 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 | A078327-001 | 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 | A078327-002 | 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 | A078327-003 | 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 | A078327-001 | 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 | A078327-002 | 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 | A078327-003 | 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 | A078327-001 | 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 | A078327-002 | 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 | A078327-003 | 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 | A078327-001 | 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 | A078327-002 | 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 | A078327-003 | 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 | A078327-001 | 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 | A078327-002 | 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 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-003 | 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 | A078327-001 | 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 | A078327-002 | 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 | A078327-003 | 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 | A078327-001 | 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 | A078327-002 | 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 | A078327-003 | 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 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078327-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078327-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078327-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078327-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078327-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078327-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078327-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078327-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078327-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078327-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078327-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078327-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078327-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078327-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078327-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078327-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078327-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078327-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078327-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078327-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078327-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078327-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078327-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078327-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078327-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078327-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078327-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078327-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078327-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078327-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078327-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078327-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078327-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078327-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-0147-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-37d4-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use SUMATRIPTAN TABLETS safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS. SUMATRIPTAN tablets, for oral use Initial U.S. Approval: 1992 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-0147-1 | Sumatriptan | 9 in 1 BOTTLE | TABLET | 9 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-0147-1 | EA - Each | 50436-0147 | fa47895e-b93f-468d-9f19-eb4f6950e2d9 | 1 | 2018-09-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-0147 | SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [UNIT DOSE SERVICES] | 4 | Legacy NDC, 1 package rows | 20180831_80282282-057f-4c99-9017-5280829313f7.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 SUCCINATE | REMEDYREPACK INC. | 73c9ac06-b55e-41e0-90ec-deb250f37eb5 | 2026-05-19 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Aurobindo Pharma Limited | b2503fff-c978-4efa-b1b4-d7740b6b26f2 | 2026-05-12 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Sportpharm LLC | d071aef6-a5bd-4f68-ba6d-03004466897c | 2026-04-24 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | A-S Medication Solutions | 62ba6fef-467a-4500-993c-51907f12a67c | 2026-02-14 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NorthStar Rx LLC | 84bfc4ba-4172-4adb-b963-4e0eb438c07a | 2026-02-13 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Preferred Pharmaceuticals, Inc. | f2e7d756-1e12-462a-a43f-a9d860b11ee8 | 2025-09-25 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Preferred Pharmaceuticals, Inc. | bf9fd9fe-095b-4478-bd2e-a5534af07761 | 2025-09-25 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Preferred Pharmaceuticals Inc. | baf37e8c-d414-4ca7-a366-97dc202372ff | 2025-09-25 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NuCare Pharmaceuticals, Inc. | 2efd4269-5657-9669-e063-6394a90a583a | 2025-02-25 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NuCare Pharmaceuticals, Inc. | 2a96f37d-03f6-678c-e063-6394a90ae0c6 | 2024-12-31 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN | Advanced Rx of Tennessee, LLC | f1a118cf-2179-572a-e053-2995a90acbb0 | 2024-12-31 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Quality Care Products, LLC | 5d1f3de0-684a-4092-be30-aa325ff20d04 | 2024-12-18 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Quality Care Products, LLC | da77dfc4-551c-4e0e-a65e-cb478f193cd9 | 2024-12-18 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN | Advanced Rx Pharmacy of Tennessee, LLC | f8c4bbfb-1586-4610-e053-6394a90a8f09 | 2024-08-27 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NuCare Pharmaceuticals,Inc. | 54c6f8f4-5466-3988-e054-00144ff8d46c | 2024-07-10 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NuCare Pharmaceuticals,Inc. | 933f6575-a4c4-0f65-e053-2a95a90ab967 | 2024-06-19 | 078327 ANDA078327 | |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NuCare Pharmaceuticals,Inc. | 85295be9-852d-4e21-e053-2991aa0a8a78 | 2024-06-14 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Proficient Rx LP | fe09fab6-b9e3-469c-9a38-bcc343dcc899 | 2023-01-01 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Asclemed USA, Inc. | 77f9f135-e840-48f0-81e8-73e08433e768 | 2022-10-11 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Proficient Rx LP | abbd2168-1523-4eb6-a75c-dc4d7d1b1c9b | 2022-06-01 | Warnings, Adverse reactions | 078327 ANDA078327 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313161 | SUMAtriptan succinate 50 MG Oral Tablet | PSN | 80282282-057f-4c99-9017-5280829313f7 | 4 |
| 313161 | sumatriptan 50 MG Oral Tablet | SCD | 80282282-057f-4c99-9017-5280829313f7 | 4 |
| 313161 | sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral Tablet | SY | 80282282-057f-4c99-9017-5280829313f7 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-0147-1 | 50436014701 | 9 in 1 BOTTLE | Historical |