Sumatriptan

Product NDC: 70518-0041
11-digit product format: 705180041
Labeler code: 70518
Product ID: 70518-0041_97aaf2b9-4326-92fd-e053-2a95a90aa4bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sumatriptan Succinate
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078327
Marketing category: ANDA
Marketing start: 2017-06-06
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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-0041		D	Discontinued by firm	2026-10-05
excluded package	package	70518-0041	70518-0041-0	D	Discontinued by firm	2026-10-05
excluded package	package	70518-0041	70518-0041-1	D	Discontinued by firm	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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
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	70518-0041-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0041-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0041-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0041-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0041-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0041-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0041-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0041-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0041-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0041-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0041-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0041-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-0041-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	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#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
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.

Product history page 1 of 4 · 129 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	A078327-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078327-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078327-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078327-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078327-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078327-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A078327-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078327-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078327-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078327-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078327-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078327-003	AB	1	`caaa826d4ba7…`
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…`

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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
1e973b2d-e028-69cd-9258-4613ba80fdc5	Product name	3	20210512
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
3eb481d3-8b69-436f-82dd-4a66345568ab	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
f6199b09-e585-7ceb-4b09-803cf5ce1ed1	Product name	1	20140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-0041	SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [REMEDYREPACK INC.]	12	Legacy NDC	20250419_9a7bd628-4909-4d7d-8285-900cedbcc62f.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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan	SUMATRIPTAN SUCCINATE	Proficient Rx LP	1042b91c-715c-4e90-b9cc-d91a17f9f7cb	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327