IMITREX

Product NDC
0173-0524
11-digit product format
001730524
Labeler code
0173
Product ID
0173-0524_1a2c2653-17a8-430b-b9c9-aa3acfe70bed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
SPRAY
Route
NASAL
Labeler
GlaxoSmithKline LLC
Application
NDA020626
Marketing category
NDA
Marketing start
1997-10-10
Marketing end
0000-00-00
Substance
SUMATRIPTAN
Active strength
5 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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0173-0524DDiscontinued by firm2026-08-17
excluded packagepackage0173-05240173-0524-00DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0173-0524-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0173-0524-00f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020626-001IMITREXSUMATRIPTAN5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26
N020626-002IMITREXSUMATRIPTAN10MG/SPRAYSPRAY / NASAL1997-08-26
N020626-003IMITREXSUMATRIPTAN20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020626-001AB
N020626-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020626-002IMITREX10MG/SPRAYSPRAY / NASAL1997-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020626-003IMITREX20MG/SPRAYSPRAY / NASALABRLD, RS1997-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020626-001IMITREX5MG/SPRAYSPRAY / NASALABRLD, RS1997-08-261e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020626-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020626-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020626-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020626-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020626-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020626-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020626-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020626-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020626-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020626-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020626-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020626-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020626-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020626-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020626-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020626-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020626-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020626-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020626-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020626-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020626-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020626-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020626-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020626-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020626-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020626-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020626-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020626-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020626-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020626-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020626-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020626-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020626-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020626-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020626-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020626-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020626-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020626-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020626-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020626-003AB1bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0524-00EA - Each0173-052460e19848-2f5f-4aae-929b-8d998d7ce11d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTANACTIVE INGREDIENT8R78F6L9VOIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
SUMATRIPTANACTIVE MOIETY8R78F6L9VOIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51IMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
WATERINACTIVE INGREDIENT059QF0KO0RIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0524IMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]22Legacy NDC20240328_cc11b09d-e6cc-4cf8-1495-5ac64d5aae5f.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUMATRIPTANSUMATRIPTANPrasco Laboratoriesf63e616b-ae0c-432b-badc-8c45023aa7252026-01-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 020626
application number: NDA020626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0524-00001730524006 CONTAINER in 1 BOX (0173-0524-00) > 1 SPRAY in 1 CONTAINER6 container1997-10-100000-00-00NoNoCurrent