Sumatriptan

Product NDC: 80425-0318
Requested package NDC: 80425-0318-1
11-digit product format: 804250318
Labeler code: 80425
Product ID: 80425-0318_20ae108a-00c6-a984-e063-6394a90aaaae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sumatriptan
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA078327
Marketing category: ANDA
Marketing start: 2023-04-07
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

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.

Product history page 1 of 4 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078327-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078327-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078327-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078327-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078327-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078327-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078327-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078327-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078327-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078327-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078327-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078327-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sumatriptan
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
f8c4bbfb-1586-4610-e053-6394a90a8f09	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
80425-0318-1	Sumatriptan	1 in 1 CARTON	TABLET	1	2
80425-0318-1	Sumatriptan	9 in 1 BLISTER PACK	TABLET	9	2
80425-0318-2	Sumatriptan	9 in 1 BLISTER PACK	TABLET	9	2
80425-0318-2	Sumatriptan	4 in 1 CARTON	TABLET	4	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0318-1	EA - Each	80425-0318	38ae2ec2-de34-4dd4-b0b6-d22066b9f76f	1	2023-06-06
80425-0318-2	EA - Each	80425-0318	0df75388-d519-4a31-8d32-f1fd155487b4	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0318	SUMATRIPTAN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 4 package rows	20240829_f8c4bbfb-1586-4610-e053-6394a90a8f09.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 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
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 ndc (package): 80425-0318-1 ndc (product): 80425-0318 ndc11 (package): 80425031801
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

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
313161	SUMAtriptan succinate 50 MG Oral Tablet	PSN	f8c4bbfb-1586-4610-e053-6394a90a8f09	2
313161	sumatriptan 50 MG Oral Tablet	SCD	f8c4bbfb-1586-4610-e053-6394a90a8f09	2
313161	sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral Tablet	SY	f8c4bbfb-1586-4610-e053-6394a90a8f09	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0318-1	80425031801	1 BLISTER PACK in 1 CARTON (80425-0318-1) / 9 TABLET in 1 BLISTER PACK	1 blister pack	2023-04-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sumatriptan Tablet	Advanced Rx Pharmacy of Tennessee, LLC	2024-08-27	HUMAN PRESCRIPTION DRUG LABEL	2