Sumatriptan

Product NDC: 70069-804
11-digit product format: 700690804
Labeler code: 70069
Product ID: 70069-804_53c62307-bd19-4418-b1b0-c0274b5595df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sumatriptan
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Somerset Therapeutics, LLC
Application: ANDA213998
Marketing category: ANDA
Marketing start: 2021-10-25
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213998-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP		2021-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213998-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213998-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-07-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213998-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213998-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213998-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213998-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213998-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213998-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213998-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213998-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213998-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213998-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213998-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213998-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213998-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213998-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213998-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213998-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213998-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213998-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213998-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213998-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213998-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213998-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213998-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213998-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213998-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213998-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213998-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213998-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213998-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213998-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213998-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213998-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213998-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313165	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
53c62307-bd19-4418-b1b0-c0274b5595df	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	SPL version
70069-804-01	Sumatriptan	0.5 mL in 1 VIAL	INJECTION, SOLUTION	0.5	1
70069-804-01	Sumatriptan	1 in 1 CARTON	INJECTION, SOLUTION	1	1
70069-804-05	Sumatriptan	5 in 1 CARTON	INJECTION, SOLUTION	5	1
70069-804-05	Sumatriptan	0.5 mL in 1 VIAL	INJECTION, SOLUTION	0.5	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70069-804-01	ML - Milliliter	70069-804	aaef9d2a-3b9c-4d93-8d99-0e504ecb126c	1	2021-12-08
70069-804-05	ML - Milliliter	70069-804	cea327bc-daf9-4996-b347-f552a0e4b82e	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70069-804	SUMATRIPTAN INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]	1	Current NDC, Legacy NDC, 4 package rows	20211026_53c62307-bd19-4418-b1b0-c0274b5595df.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan	SUMATRIPTAN	Armas Pharmaceuticals Inc.	65147b04-0b6b-4d30-9710-d5cdce85e8f5	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213998 application number: ANDA213998
Sumatriptan	SUMATRIPTAN	A-S Medication Solutions	7f34f450-d6f3-49a8-b55a-8e1e4a9ee950	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213998 application number: ANDA213998
Sumatriptan	SUMATRIPTAN	Caplin Steriles Limited	01293e09-d49a-411d-9647-6f23318ac201	2024-09-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213998 application number: ANDA213998
Sumatriptan	SUMATRIPTAN SUCCINATE	Xellia Pharmaceuticals USA LLC	f42c6e00-e693-48f3-8e84-c3f139e1adf5	2021-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213998 application number: ANDA213998
Sumatriptan	SUMATRIPTAN	Somerset Therapeutics, LLC	53c62307-bd19-4418-b1b0-c0274b5595df	2021-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213998 application number: ANDA213998 ndc (product): 70069-804

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
313165	SUMAtriptan 6 MG in 0.5 ML Injection	PSN	53c62307-bd19-4418-b1b0-c0274b5595df	1
313165	0.5 ML sumatriptan 12 MG/ML Injection	SCD	53c62307-bd19-4418-b1b0-c0274b5595df	1
313165	sumatriptan (as sumatriptan succinate) 12 MG/ML Injection	SY	53c62307-bd19-4418-b1b0-c0274b5595df	1
313165	sumatriptan 6 MG per 0.5 ML Injection	SY	53c62307-bd19-4418-b1b0-c0274b5595df	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70069-804-01	70069080401	1 VIAL in 1 CARTON (70069-804-01) / .5 mL in 1 VIAL	1 vial	2021-10-25	0000-00-00	No	No	Current
70069-804-05	70069080405	5 VIAL in 1 CARTON (70069-804-05) / .5 mL in 1 VIAL	5 vial	2021-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sumatriptan	Somerset Therapeutics, LLC \| Caplin Steriles Limited	2021-09-22	Human Prescription Drug Label	1