SUMATRIPTAN

Product NDC: 66993-081
11-digit product format: 669930081
Labeler code: 66993
Product ID: 66993-081_06b6df24-20eb-4b22-b8e3-591ae1f3518a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sumatriptan
Dosage form: SPRAY
Route: NASAL
Labeler: Prasco Laboratories
Application: NDA020626
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-07-01
Substance: SUMATRIPTAN
Active strength: 5 mg/100uL
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 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
N020626-001	IMITREX	SUMATRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26
N020626-002	IMITREX	SUMATRIPTAN	10MG/SPRAY	SPRAY / NASAL			1997-08-26
N020626-003	IMITREX	SUMATRIPTAN	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020626-001	AB
N020626-003	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	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020626-002	IMITREX	10MG/SPRAY	SPRAY / NASAL			1997-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020626-003	IMITREX	20MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020626-001	IMITREX	5MG/SPRAY	SPRAY / NASAL	AB	RLD, RS	1997-08-26	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N020626-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020626-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020626-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020626-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020626-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020626-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020626-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020626-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020626-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020626-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020626-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020626-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020626-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020626-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020626-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020626-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020626-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020626-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020626-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020626-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020626-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020626-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020626-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020626-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020626-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020626-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020626-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020626-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020626-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020626-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020626-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020626-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020626-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020626-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020626-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020626-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020626-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020626-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020626-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020626-003	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: SUMATRIPTAN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SUMATRIPTAN	5 mg/100uL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8R78F6L9VO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313159	Internal RxNorm lookup
314227	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
f63e616b-ae0c-432b-badc-8c45023aa725	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
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
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
66993-081-69	SUMATRIPTAN	6 in 1 BOX	SPRAY	6		8
66993-081-69	SUMATRIPTAN	100 uL in 1 CONTAINER	SPRAY	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-081-69	EA - Each	66993-081	9a5489fb-5e95-4f3c-bd72-06314f7555a5	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-081	SUMATRIPTAN SPRAY [PRASCO LABORATORIES]	6	Current NDC, Legacy NDC, 2 package rows	20240404_f63e616b-ae0c-432b-badc-8c45023aa725.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
SUMATRIPTAN	SUMATRIPTAN	Prasco Laboratories	f63e616b-ae0c-432b-badc-8c45023aa725	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020626 application number: NDA020626 ndc (product): 66993-081

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8R78F6L9VO	SUMATRIPTAN	103628-46-2	SUMATRIPTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314227	SUMAtriptan 20 MG/ACTUAT Nasal Spray	PSN	f63e616b-ae0c-432b-badc-8c45023aa725	8
313159	SUMAtriptan 5 MG/ACTUAT Nasal Spray	PSN	f63e616b-ae0c-432b-badc-8c45023aa725	8
314227	sumatriptan 20 MG/ACTUAT Nasal Spray	SCD	f63e616b-ae0c-432b-badc-8c45023aa725	8
313159	sumatriptan 5 MG/ACTUAT Nasal Spray	SCD	f63e616b-ae0c-432b-badc-8c45023aa725	8
314227	sumatriptan 20 MG/0.1 ML Nasal Spray	SY	f63e616b-ae0c-432b-badc-8c45023aa725	8
313159	sumatriptan 5 MG/0.1 ML Nasal Spray	SY	f63e616b-ae0c-432b-badc-8c45023aa725	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-081-69	66993008169	6 CONTAINER in 1 BOX (66993-081-69) / 100 uL in 1 CONTAINER	6 container	2020-07-01	0000-00-00	No	No	Current