Sumatriptan

Product NDC: 68071-3755
Requested package NDC: 68071-3755-9
11-digit product format: 680713755
Labeler code: 68071
Product ID: 68071-3755_2a97343a-9a5d-e604-e063-6394a90af65c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sumatriptan Succinate
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA078327
Marketing category: ANDA
Marketing start: 2018-06-18
Substance: SUMATRIPTAN SUCCINATE
Active strength: 100 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

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

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A078327-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078327-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078327-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A078327-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078327-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078327-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan	SUMATRIPTAN SUCCINATE	REMEDYREPACK INC.	73c9ac06-b55e-41e0-90ec-deb250f37eb5	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	Aurobindo Pharma Limited	b2503fff-c978-4efa-b1b4-d7740b6b26f2	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	Sportpharm LLC	d071aef6-a5bd-4f68-ba6d-03004466897c	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	A-S Medication Solutions	62ba6fef-467a-4500-993c-51907f12a67c	2026-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	NorthStar Rx LLC	84bfc4ba-4172-4adb-b963-4e0eb438c07a	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	Preferred Pharmaceuticals, Inc.	f2e7d756-1e12-462a-a43f-a9d860b11ee8	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	Preferred Pharmaceuticals, Inc.	bf9fd9fe-095b-4478-bd2e-a5534af07761	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	Preferred Pharmaceuticals Inc.	baf37e8c-d414-4ca7-a366-97dc202372ff	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals, Inc.	2efd4269-5657-9669-e063-6394a90a583a	2025-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals, Inc.	2a96f37d-03f6-678c-e063-6394a90ae0c6	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327 ndc (package): 68071-3755-9 ndc (product): 68071-3755 ndc11 (package): 68071375509
Sumatriptan	SUMATRIPTAN	Advanced Rx of Tennessee, LLC	f1a118cf-2179-572a-e053-2995a90acbb0	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	Quality Care Products, LLC	5d1f3de0-684a-4092-be30-aa325ff20d04	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	Quality Care Products, LLC	da77dfc4-551c-4e0e-a65e-cb478f193cd9	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN	Advanced Rx Pharmacy of Tennessee, LLC	f8c4bbfb-1586-4610-e053-6394a90a8f09	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals,Inc.	54c6f8f4-5466-3988-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals,Inc.	933f6575-a4c4-0f65-e053-2a95a90ab967	2024-06-19		Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals,Inc.	85295be9-852d-4e21-e053-2991aa0a8a78	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	Proficient Rx LP	fe09fab6-b9e3-469c-9a38-bcc343dcc899	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	Asclemed USA, Inc.	77f9f135-e840-48f0-81e8-73e08433e768	2022-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327
Sumatriptan	SUMATRIPTAN SUCCINATE	Proficient Rx LP	abbd2168-1523-4eb6-a75c-dc4d7d1b1c9b	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078327 application number: ANDA078327

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SUMATRIPTAN SUCCINATE	100 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
313160	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
2a96f37d-03f6-678c-e063-6394a90ae0c6	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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3755-9	Sumatriptan	1 in 1 CARTON	TABLET	1		1
68071-3755-9	Sumatriptan	9 in 1 BLISTER PACK	TABLET	9		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3755	SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [NUCARE PHARMACEUTICALS, INC.]	1	Current NDC, 2 package rows	20250101_2a96f37d-03f6-678c-e063-6394a90ae0c6.zip

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
313160	SUMAtriptan succinate 100 MG Oral Tablet	PSN	2a96f37d-03f6-678c-e063-6394a90ae0c6	1
313160	sumatriptan 100 MG Oral Tablet	SCD	2a96f37d-03f6-678c-e063-6394a90ae0c6	1
313160	sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral Tablet	SY	2a96f37d-03f6-678c-e063-6394a90ae0c6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3755-9	68071375509	1 BLISTER PACK in 1 CARTON (68071-3755-9) / 9 TABLET in 1 BLISTER PACK	1 blister pack	2024-12-31	No	No	Current