Sumatriptan Succinate

Product NDC: 55648-728
11-digit product format: 556480728
Labeler code: 55648
Product ID: 55648-728_677214c1-8f46-4345-8dae-8f0bb97154fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sumatriptan Succinate
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Wockhardt Limited
Application: ANDA078593
Marketing category: ANDA
Marketing start: 2009-02-06
Marketing end: 0000-00-00
Substance: SUMATRIPTAN SUCCINATE
Active strength: 6 mg/.5mL
Pharmacologic classes: Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55648-728		I	Inactivated by FDA		2026-10-05
excluded package	package	55648-728	55648-728-01	I	Inactivated by FDA		2026-10-05

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.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-728-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-728-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-728-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-728-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-728-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-728-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-728-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-728-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-728-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-728-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-728-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-728-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-728-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-728-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-728-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55648-728-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55648-728-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55648-728-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55648-728-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55648-728-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	55648-728-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55648-728-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078593-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP		2009-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078593-001	AP

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078593-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2009-02-06	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078593-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078593-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078593-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078593-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078593-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078593-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078593-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078593-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078593-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078593-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078593-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078593-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078593-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078593-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078593-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078593-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078593-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078593-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078593-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078593-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078593-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078593-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078593-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078593-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078593-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078593-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078593-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078593-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078593-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078593-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078593-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078593-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078593-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078593-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078593-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078593-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078593-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078593-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078593-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078593-001	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2	Product name	4	20250724
2839c963-7eb3-970a-287f-ff1b6d381268	Product name	2	20250103
1e973b2d-e028-69cd-9258-4613ba80fdc5	Product name	3	20210512
3eb481d3-8b69-436f-82dd-4a66345568ab	Product name	1	20190611
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877c	Product name	1	20160303
49615343-b619-4365-8118-8f2ed6046e78	Product name	1	20160224
a6319377-430a-43db-82f9-30d1d9d89cf8	Product name	1	20151216
f6199b09-e585-7ceb-4b09-803cf5ce1ed1	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55648-728-01	2020-01-31	C162847	48780-1	9d75b9d0-0139-f424-e053-dadaa90a57ce	PRESCRIBING INFORMATION Sumatriptan Succinate Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55648-728-01	Sumatriptan Succinate	5 in 1 CARTON	INJECTION	5		1
55648-728-01	Sumatriptan Succinate	0.5 mL in 1 VIAL	INJECTION	0.5		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SUMATRIPTAN SUCCINATE	ACTIVE INGREDIENT	J8BDZ68989	SUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT LIMITED]	1
SUMATRIPTAN	ACTIVE MOIETY	8R78F6L9VO	SUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT LIMITED]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT LIMITED]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-728	SUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT LIMITED]	1	Legacy NDC, 2 package rows	20120305_cc5fed6e-37b5-415c-af2c-31e2bfb83c7c.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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	44d6d757-489c-4262-a518-af8c470734d6	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078593 application number: ANDA078593

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J8BDZ68989	SUMATRIPTAN SUCCINATE	103628-48-4	SUMATRIPTAN SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313165	SUMAtriptan 6 MG in 0.5 ML Injection	PSN	cc5fed6e-37b5-415c-af2c-31e2bfb83c7c	1
313165	0.5 ML sumatriptan 12 MG/ML Injection	SCD	cc5fed6e-37b5-415c-af2c-31e2bfb83c7c	1
313165	sumatriptan (as sumatriptan succinate) 12 MG/ML Injection	SY	cc5fed6e-37b5-415c-af2c-31e2bfb83c7c	1
313165	sumatriptan 6 MG per 0.5 ML Injection	SY	cc5fed6e-37b5-415c-af2c-31e2bfb83c7c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55648-728-01	55648072801	5 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRESCRIBING INFORMATION Sumatriptan Succinate Injection	Wockhardt Limited	2012-03-05	HUMAN PRESCRIPTION DRUG LABEL	1