FDA.reportPublic FDA data

Sumansetron

Product NDC
59088-772
11-digit product format
590880772
Labeler code
59088
Product ID
59088-772_f2054b5e-a881-1bd5-e053-2a95a90a015c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan succinate, ondansetron
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-01-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Sumansetron
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198052Internal RxNorm lookup
313161Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b69f0762-a2f7-28c7-e053-2995a90a0484Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-772-00Sumansetron1 in 1 PACKAGEKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-772-00EA - Each59088-772ca22a062-5750-410b-915a-9c05b9a32c0e12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-772SUMANSETRON (SUMATRIPTAN SUCCINATE, ONDANSETRON) KIT [PURETEK CORPORATION]2Current NDC, Legacy NDC, 1 package rows20230112_b69f0762-a2f7-28c7-e053-2995a90a0484.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
SumansetronSUMATRIPTAN SUCCINATE, ONDANSETRONPureTek Corporationb69f0762-a2f7-28c7-e053-2995a90a04842023-01-11Warnings, Adverse reactionsExact identifier
ndc (product): 59088-772

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNb69f0762-a2f7-28c7-e053-2995a90a04842
313161SUMAtriptan succinate 50 MG Oral TabletPSNb69f0762-a2f7-28c7-e053-2995a90a04842
198052ondansetron 4 MG Oral TabletSCDb69f0762-a2f7-28c7-e053-2995a90a04842
313161sumatriptan 50 MG Oral TabletSCDb69f0762-a2f7-28c7-e053-2995a90a04842
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYb69f0762-a2f7-28c7-e053-2995a90a04842
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYb69f0762-a2f7-28c7-e053-2995a90a04842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-772-00590880772001 KIT in 1 PACKAGE (59088-772-00) * 9 BLISTER PACK in 1 CARTON (55111-292-09) / 9 TABLET in 1 BLISTER PACK * 30 TABLET, FILM COATED in 1 BOTTLE (45963-538-30) 1 kit2021-01-010000-00-00NoNoCurrent