IMITREX

Product NDC: 0173-0478
11-digit product format: 001730478
Labeler code: 0173
Product ID: 0173-0478_f5834e77-047f-43ab-8b9c-37d3b34afc27
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sumatriptan
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: GlaxoSmithKline LLC
Application: NDA020080
Marketing category: NDA
Marketing start: 1997-01-27
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 · 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SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28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IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`011fe1cb6892…`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…`

Additional Listing Data#

Finished product: Yes
Brand name base: IMITREX
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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
758523	Internal RxNorm lookup
860088	Internal RxNorm lookup
1657160	Internal RxNorm lookup
1657173	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
fee7d073-0b99-48f2-7985-0d8cf970894b	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	Strength	SPL version
0173-0478-00	IMITREX	0.5 mL in 1 SYRINGE	INJECTION	0.5		29
0173-0478-00	IMITREX	2 in 1 CARTON	INJECTION	2		29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0478-00	ML - Milliliter	0173-0478	4cd327b4-2fba-46c0-83e5-182b421c5db7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SUMATRIPTAN SUCCINATE	ACTIVE INGREDIENT	J8BDZ68989	IMITREX (SUMATRIPTAN SUCCINATE) INJECTION [GLAXOSMITHKLINE LLC]	14
SUMATRIPTAN	ACTIVE MOIETY	8R78F6L9VO	IMITREX (SUMATRIPTAN SUCCINATE) INJECTION [GLAXOSMITHKLINE LLC]	14
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	IMITREX (SUMATRIPTAN SUCCINATE) INJECTION [GLAXOSMITHKLINE LLC]	14
WATER	INACTIVE INGREDIENT	059QF0KO0R	IMITREX (SUMATRIPTAN SUCCINATE) INJECTION [GLAXOSMITHKLINE LLC]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0173-0478	IMITREX (SUMATRIPTAN) INJECTION [GLAXOSMITHKLINE LLC]	27	Current NDC, Legacy NDC, 2 package rows	20240828_fee7d073-0b99-48f2-7985-0d8cf970894b.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 ndc (product): 0173-0478

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
758523	IMITREX 4 MG in 0.5 ML Cartridge	PSN	fee7d073-0b99-48f2-7985-0d8cf970894b	29
860088	IMITREX 6 MG in 0.5 ML Cartridge	PSN	fee7d073-0b99-48f2-7985-0d8cf970894b	29
1657173	SUMAtriptan 4 MG in 0.5 ML Cartridge	PSN	fee7d073-0b99-48f2-7985-0d8cf970894b	29
1657160	SUMAtriptan 6 MG in 0.5 ML Cartridge	PSN	fee7d073-0b99-48f2-7985-0d8cf970894b	29
860088	0.5 ML sumatriptan 12 MG/ML Cartridge [Imitrex]	SBD	fee7d073-0b99-48f2-7985-0d8cf970894b	29
758523	0.5 ML sumatriptan 8 MG/ML Cartridge [Imitrex]	SBD	fee7d073-0b99-48f2-7985-0d8cf970894b	29
1657160	0.5 ML sumatriptan 12 MG/ML Cartridge	SCD	fee7d073-0b99-48f2-7985-0d8cf970894b	29
1657173	0.5 ML sumatriptan 8 MG/ML Cartridge	SCD	fee7d073-0b99-48f2-7985-0d8cf970894b	29
860088	0.5 ML Imitrex 12 MG/ML Cartridge	SY	fee7d073-0b99-48f2-7985-0d8cf970894b	29
758523	0.5 ML Imitrex 8 MG/ML Cartridge	SY	fee7d073-0b99-48f2-7985-0d8cf970894b	29
758523	Imitrex 4 MG (as sumatriptan succinate) per 0.5 ML Cartridge	SY	fee7d073-0b99-48f2-7985-0d8cf970894b	29
758523	Imitrex 4 MG per 0.5 ML Cartridge	SY	fee7d073-0b99-48f2-7985-0d8cf970894b	29
860088	Imitrex 6 MG (as sumatriptan succinate) per 0.5 ML Cartridge	SY	fee7d073-0b99-48f2-7985-0d8cf970894b	29
860088	Imitrex 6 MG per 0.5 ML Cartridge	SY	fee7d073-0b99-48f2-7985-0d8cf970894b	29
1657173	sumatriptan 4 MG (as sumatriptan succinate) per 0.5 ML Cartridge	SY	fee7d073-0b99-48f2-7985-0d8cf970894b	29
1657173	sumatriptan 4 MG per 0.5 ML Cartridge	SY	fee7d073-0b99-48f2-7985-0d8cf970894b	29
1657160	sumatriptan 6 MG (as sumatriptan succinate) per 0.5 ML Cartridge	SY	fee7d073-0b99-48f2-7985-0d8cf970894b	29
1657160	sumatriptan 6 MG per 0.5 ML Cartridge	SY	fee7d073-0b99-48f2-7985-0d8cf970894b	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0173-0478-00	00173047800	2 SYRINGE in 1 CARTON (0173-0478-00) / .5 mL in 1 SYRINGE	2 syringe	1997-01-27	0000-00-00	No	No	Current