SUMATRIPTAN

Product NDC: 66993-083
Requested package NDC: 66993-083-79
11-digit product format: 669930083
Labeler code: 66993
Product ID: 66993-083_8e63cabf-8605-41ad-a082-8d3fdd38ee5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sumatriptan
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Prasco Laboratories
Application: NDA020080
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-07-01
Marketing end: 0000-00-00
Substance: SUMATRIPTAN SUCCINATE
Active strength: 4 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	66993-083	66993-083-79	D	Discontinued by firm		2026-08-11

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	RLD / RS	Approval date
N020080-001	IMITREX	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28
N020080-002	IMITREX STATDOSE	SUMATRIPTAN SUCCINATE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	2006-02-01
N020080-003	IMITREX STATDOSE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020080-002	AB
N020080-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	2006-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	2006-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2006-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2006-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2006-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2006-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2006-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2006-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2006-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2006-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2006-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2006-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2006-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 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	N020080-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020080-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020080-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020080-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020080-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020080-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020080-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020080-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020080-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020080-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020080-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020080-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020080-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020080-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020080-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020080-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020080-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020080-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020080-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020080-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020080-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020080-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020080-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020080-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020080-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020080-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020080-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020080-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020080-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020080-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020080-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020080-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020080-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020080-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020080-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020080-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020080-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020080-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020080-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020080-003	AB	1	`5aa47cf7b7d7…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-083-79	ML - Milliliter	66993-083	373f18f0-dba3-41ec-9f48-38e53bf8d16d	1	2020-08-06
66993-083-98	ML - Milliliter	66993-083	a4837a0b-3eae-4e16-98e7-a91453d0a77d	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-083	SUMATRIPTAN INJECTION, SOLUTION [PRASCO LABORATORIES]	7	Legacy NDC	20240828_19d3c342-19fe-4f71-99cd-57dcdab03cf7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IMITREX	SUMATRIPTAN	GlaxoSmithKline LLC	fee7d073-0b99-48f2-7985-0d8cf970894b	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020080 application number: NDA020080

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-083-79	66993008379	2 SYRINGE in 1 CARTON (66993-083-79) > .5 mL in 1 SYRINGE	2 syringe	2020-07-01	0000-00-00	No	No	Current