FDA.reportPublic FDA data

NDC 80425-0318-01 - Sumatriptan

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0318
Requested NDC
80425-0318-01
Package NDCs from labels
80425-0318-1, 80425-0318-2, 80425-0318-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-08-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sumatriptan - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-08-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0318-1Sumatriptan1 in 1 CARTONTABLET12
80425-0318-1Sumatriptan9 in 1 BLISTER PACKTABLET92
80425-0318-2Sumatriptan9 in 1 BLISTER PACKTABLET92
80425-0318-2Sumatriptan4 in 1 CARTONTABLET42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0318SUMATRIPTAN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 4 package rows20240829_f8c4bbfb-1586-4610-e053-6394a90a8f09.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0318-1EA - Each80425-031838ae2ec2-de34-4dd4-b0b6-d22066b9f76f12023-06-06
80425-0318-2EA - Each80425-03180df75388-d519-4a31-8d32-f1fd155487b412023-06-06

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 4 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.85295be9-852d-4e21-e053-2991aa0a8a782024-06-14Warnings, Adverse reactionsExact identifier
application number: ANDA078327
rxcui: 313161
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEFresenius Kabi USA, LLCb183c7ba-2cc6-4854-a9a6-71ccd35925862024-04-12Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANA-S Medication Solutionsf675d0db-f356-4eda-be62-b00af476326c2024-01-07Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptan succinateSUMATRIPTAN SUCCINATEA-S Medication Solutions97016a59-3b49-4134-85aa-8c866f2856012023-11-22Warnings, Adverse reactionsExact identifier
rxcui: 315223
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENorthStar Rx LLC38fd19bf-b7aa-812c-8a74-2414dfec45f42023-03-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumansetronSUMATRIPTAN SUCCINATE, ONDANSETRONPureTek Corporationb69f0762-a2f7-28c7-e053-2995a90a04842023-01-11Warnings, Adverse reactionsExact identifier
rxcui: 313161
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPfe09fab6-b9e3-469c-9a38-bcc343dcc8992023-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA078327
rxcui: 313160
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEAsclemed USA, Inc.77f9f135-e840-48f0-81e8-73e08433e7682022-10-11Warnings, Adverse reactionsExact identifier
application number: ANDA078327
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPabbd2168-1523-4eb6-a75c-dc4d7d1b1c9b2022-06-01Warnings, Adverse reactionsExact identifier
application number: ANDA078327
rxcui: 315223
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LP1042b91c-715c-4e90-b9cc-d91a17f9f7cb2022-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA078327
rxcui: 313161
unii: J8BDZ68989
sumatriptan succinateSUMATRIPTAN SUCCINATEProficient Rx LP9f4d487a-c5f7-4707-976b-64e738c98d452022-04-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANSUN PHARMACEUTICAL INDUSTRIES, INC.c87cf537-9f7f-400e-ac4b-86e6f7e787752022-01-19Warnings, Adverse reactionsExact identifier
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddy's Laboratories Limited4e26764d-ce26-e5ac-e6db-0f1f7a1d5c2b2021-12-21Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEXellia Pharmaceuticals USA LLCf42c6e00-e693-48f3-8e84-c3f139e1adf52021-11-18Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANSomerset Therapeutics, LLC53c62307-bd19-4418-b1b0-c0274b5595df2021-09-22Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANProficient Rx LP5cba3661-9b16-416b-b0c0-bbb12549d48f2021-01-01Warnings, Adverse reactionsExact identifier
rxcui: 315223
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANProficient Rx LP121e36fb-471b-4318-bc47-b087ad68c6f72021-01-01Warnings, Adverse reactionsExact identifier
rxcui: 313160
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANHikma Pharmaceuticals USA Inc.2b417f8c-9e5b-45a1-b8af-183818258df92021-01-01Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEAsclemed USA, Inc.b16886d0-224b-4d83-85c4-bc3eb3606c172020-10-24Warnings, Adverse reactionsExact identifier
rxcui: 313161
unii: J8BDZ68989
sumatriptan succinateSUMATRIPTAN SUCCINATEProficient Rx LPd556563f-ad71-45c1-829a-cc11983bce0c2020-03-01Warnings, Adverse reactionsExact identifier
rxcui: 313161
unii: J8BDZ68989

Reported adverse events (FAERS/openFDA)#

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