sumatriptan

Product NDC: 83270-152
Requested package NDC: 83270-152-07
11-digit product format: 832700152
Labeler code: 83270
Product ID: 83270-152_4b3f1ed8-151c-79f2-e063-6394a90ada00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sumatriptan
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: ONESOURCE SPECIALTY PHARMA LIMITED
Application: ANDA090314
Marketing category: ANDA
Marketing start: 2026-02-02
Substance: SUMATRIPTAN SUCCINATE
Active strength: 6 mg/.5mL
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: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090314-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS			2010-06-10
A090314-002	SUMATRIPTAN SUCCINATE (AUTOINJECTOR)	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB		2026-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090314-002	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 2 · 46 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	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090314-002	SUMATRIPTAN SUCCINATE (AUTOINJECTOR)	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2026-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090314-002	SUMATRIPTAN SUCCINATE (AUTOINJECTOR)	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2026-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2010-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2010-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2010-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2010-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2010-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2010-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2010-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2010-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090314-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090314-002	AB	1	`caaa826d4ba7…`
2019-12-13 00:20 UTC	2019-12	A090314-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090314-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090314-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090314-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090314-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090314-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090314-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090314-001	AP	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090314-002	AB	1	`a50c72e98297…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SUMATRIPTAN SUCCINATE	6 mg/.5mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
727339	Internal RxNorm lookup
1657151	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
587e6bb5-a665-4396-814e-ce893a20290b	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
83270-152-07	sumatriptan	0.5 mL in 1 SYRINGE	INJECTION, SOLUTION	0.5		2
83270-152-07	sumatriptan	2 in 1 CARTON	INJECTION, SOLUTION	2		2

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUMATRIPTAN	SUMATRIPTAN	Golden State Medical Supply, Inc.	4b4915d3-be7a-e5fa-e063-6294a90a7f98	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090314 application number: ANDA090314
SUMATRIPTAN	SUMATRIPTAN	Strides Pharma Science Limited	1909558d-8342-4af0-9487-eecdaac70070	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090314 application number: ANDA090314
sumatriptan	SUMATRIPTAN	ONESOURCE SPECIALTY PHARMA LIMITED	587e6bb5-a665-4396-814e-ce893a20290b	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090314 application number: ANDA090314 ndc (package): 83270-152-07 ndc (product): 83270-152 ndc11 (package): 83270015207

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J8BDZ68989	SUMATRIPTAN SUCCINATE	103628-48-4	SUMATRIPTAN SUCCINATE
8R78F6L9VO	SUMATRIPTAN	103628-46-2	sumatriptan

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1657151	SUMAtriptan 6 MG in 0.5 ML Auto-Injector	PSN	587e6bb5-a665-4396-814e-ce893a20290b	2
727339	SUMAtriptan 6 MG in 0.5 ML Prefilled Syringe	PSN	587e6bb5-a665-4396-814e-ce893a20290b	2
1657151	0.5 ML sumatriptan 12 MG/ML Auto-Injector	SCD	587e6bb5-a665-4396-814e-ce893a20290b	2
727339	0.5 ML sumatriptan 12 MG/ML Prefilled Syringe	SCD	587e6bb5-a665-4396-814e-ce893a20290b	2
1657151	sumatriptan (as sumatriptan succinate) 6 MG per 0.5 ML Auto-Injector	SY	587e6bb5-a665-4396-814e-ce893a20290b	2
727339	sumatriptan (as sumatriptan succinate) 6 MG per 0.5 ML Prefilled Syringe	SY	587e6bb5-a665-4396-814e-ce893a20290b	2
727339	sumatriptan 6 MG per 0.5 ML Prefilled Syringe	SY	587e6bb5-a665-4396-814e-ce893a20290b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83270-152-07	83270015207	2 SYRINGE in 1 CARTON (83270-152-07) / .5 mL in 1 SYRINGE	2 syringe	2026-02-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
sumatriptan	ONESOURCE SPECIALTY PHARMA LIMITED \| Onesource Specialty Pte. Limited \| ONESOURCE SPECIALTY PHARMA LIMITED - Sterile Product Divison	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL	2