SUMATRIPTAN

Product NDC
0781-6524
Requested package NDC
0781-6524-86
11-digit product format
007816524
Labeler code
0781
Product ID
0781-6524_f9989be0-513c-4c19-a4cf-4069531895ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
SPRAY
Route
NASAL
Labeler
Sandoz Inc
Application
NDA020626
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2008-09-11
Marketing end
2022-01-31
Substance
SUMATRIPTAN
Active strength
5 mg/100uL
Pharmacologic classes
Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0781-65240781-6524-86DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
0781-6524-06EA - Each0781-65249ef55ee7-f4ed-4dcf-b710-b207aa41afdb12012-07-24
0781-6524-86EA - Each0781-6524d8be3da2-8d2a-46e6-9d1a-070ad975dedf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTANACTIVE INGREDIENT8R78F6L9VOSUMATRIPTAN SPRAY [SANDOZ INC]9
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SPRAY [SANDOZ INC]9
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51SUMATRIPTAN SPRAY [SANDOZ INC]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISUMATRIPTAN SPRAY [SANDOZ INC]9
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FSUMATRIPTAN SPRAY [SANDOZ INC]9
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFSUMATRIPTAN SPRAY [SANDOZ INC]9
WATERINACTIVE INGREDIENT059QF0KO0RSUMATRIPTAN SPRAY [SANDOZ INC]9

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
0781-6524-86007816524866 CONTAINER in 1 BOX (0781-6524-86) > 100 uL in 1 CONTAINER (0781-6524-06) 6 container2008-09-112022-01-31NoNoCurrent