Sumatriptan Succinate

Product NDC: 72189-433
Requested package NDC: 72189-433-09
11-digit product format: 721890433
Labeler code: 72189
Product ID: 72189-433_2c4d7d0d-6552-336d-e063-6294a90a0ea4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sumatriptan Succinate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA078295
Marketing category: ANDA
Marketing start: 2023-03-13
Substance: SUMATRIPTAN SUCCINATE
Active strength: 50 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: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-433	72189-433-09	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-433	72189-433-09	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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	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.

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	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL		2009-08-10	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Sumatriptan Succinate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SUMATRIPTAN SUCCINATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J8BDZ68989	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313161	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f6c907a3-9624-f893-e053-6294a90a31af	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-433-09	Sumatriptan Succinate	9 in 1 BOTTLE	TABLET, FILM COATED	9		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-433-09	EA - Each	72189-433	d4c960c0-5a9e-40ed-8b27-72f688c13456	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-433	SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DIRECT_RX]	3	Current NDC, 1 package rows	20250123_f6c907a3-9624-f893-e053-6294a90a31af.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 · 6 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (ANDA): 078295 application number: ANDA078295
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Direct_Rx	f6c95873-576d-a1c2-e053-6294a90a3ff9	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078295 application number: ANDA078295
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Direct_Rx	f6c907a3-9624-f893-e053-6294a90a31af	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078295 application number: ANDA078295 ndc (package): 72189-433-09 ndc (product): 72189-433 ndc11 (package): 72189043309
sumatriptan succinate	SUMATRIPTAN SUCCINATE	A-S Medication Solutions	97016a59-3b49-4134-85aa-8c866f285601	2023-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078295 application number: ANDA078295
sumatriptan succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	9f4d487a-c5f7-4707-976b-64e738c98d45	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078295 application number: ANDA078295
sumatriptan succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	d556563f-ad71-45c1-829a-cc11983bce0c	2020-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078295 application number: ANDA078295

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
313161	SUMAtriptan succinate 50 MG Oral Tablet	PSN	f6c907a3-9624-f893-e053-6294a90a31af	3
313161	sumatriptan 50 MG Oral Tablet	SCD	f6c907a3-9624-f893-e053-6294a90a31af	3
313161	sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral Tablet	SY	f6c907a3-9624-f893-e053-6294a90a31af	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-433-09	72189043309	9 TABLET, FILM COATED in 1 BOTTLE (72189-433-09)	2023-03-13	No	No	Current