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 2 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SumatriptanSUMATRIPTAN SUCCINATENorthStar Rx LLC84bfc4ba-4172-4adb-b963-4e0eb438c07a2026-02-13Warnings, Adverse reactionsExact identifier
application number: ANDA078327
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
sumatriptanSUMATRIPTANONESOURCE SPECIALTY PHARMA LIMITED4996682c-cd85-6e39-e063-6294a90a90ae2026-01-30Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptanSUMATRIPTANONESOURCE SPECIALTY PHARMA LIMITEDb4240c6e-6b9e-405f-82e6-a3d5bd9e6f292026-01-30Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEAlembic Pharmaceuticals Inc.0e8b65f7-9d3b-42f2-8d7e-69b1433659802026-01-29Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANBaxter Healthcare Corporationd13df081-648c-44c0-9854-5a1bfe23ae892026-01-28Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddys Laboratories Inc.,8fef1176-7a38-eca3-22ca-83efe5ca66202026-01-21Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATESun Pharmaceutical Industries, Inc.f235152e-dd8d-4679-9d9f-404fe5ff4fba2026-01-08Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
IMITREXSUMATRIPTANGlaxoSmithKline LLC584abe73-8290-4484-ff8e-5890831c095e2025-12-09Warnings, Adverse reactionsExact identifier
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
IMITREXSUMATRIPTANGlaxoSmithKline LLCfee7d073-0b99-48f2-7985-0d8cf970894b2025-12-09Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan and Naproxen SodiumSUMATRIPTAN AND NAPROXEN SODIUMNorthStar RxLLC3f2ec27e-0e96-4028-a1fa-114e6d5014642025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEAlembic Pharmaceuticals Limited16b7e44d-afa0-4177-80ef-c3ae9a78a4e12025-11-17Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANEugia US LLCc009976a-4e29-4aeb-9e55-a88766ebb1fb2025-11-12Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan and Naproxen SodiumSUMATRIPTAN AND NAPROXEN SODIUMSun Pharmaceutical Industries, Inc.96ed12a3-fa76-4afd-bee8-1ab19eb607f32025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.f2e7d756-1e12-462a-a43f-a9d860b11ee82025-09-25Warnings, Adverse reactionsExact identifier
application number: ANDA078327
rxcui: 313161
unii: J8BDZ68989
SumatriptanSUMATRIPTANEugia US LLC9b1bb8c9-be3a-47c3-b3bc-9c983cde7d232025-05-29Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptanSUMATRIPTANRising Pharma Holdings, Inc.352d2ab3-d2c7-48c8-bcd4-d46ed9bdfa852025-05-21Warnings, Adverse reactionsExact identifier
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
Zembrace SymTouchSUMATRIPTAN SUCCINATETonix Medicines, Inc.3eb49807-fa9d-4a0d-9a3c-76de5b23b01b2025-02-28Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2efd4269-5657-9669-e063-6394a90a583a2025-02-25Warnings, Adverse reactionsExact identifier
application number: ANDA078327
rxcui: 313161
unii: J8BDZ68989
SumatriptanSUMATRIPTANNuCare Pharmaceuticals,Inc.082d05f6-3850-0fa2-e063-6294a90a0c662025-02-03Warnings, Adverse reactionsExact identifier
rxcui: 313161
unii: J8BDZ68989
SumatriptanSUMATRIPTANDirect_Rxefb7ec4e-0a5d-2aae-e053-2a95a90aebf22025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 313160
unii: J8BDZ68989

Reported adverse events (FAERS/openFDA)#

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