FDA.reportPublic FDA data

NDC 80425-0258-01 - 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
80425-0258
Requested NDC
80425-0258-01
Package NDCs from labels
80425-0258-1, 80425-0258-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
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, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0258-1Sumatriptan9 in 1 BLISTER PACKTABLET, FILM COATED92
80425-0258-1Sumatriptan1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0258SUMATRIPTAN TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 2 package rows20250102_f27ca3c0-9de0-ff9c-e053-2a95a90ab894.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0258-1EA - Each80425-02581d093b12-1514-4166-86d7-8f750f34623f12023-06-06

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 1 of 5 · 85 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SumatriptanSUMATRIPTANPreferred Pharmaceuticals Inc.ff08b9ee-03bf-4f5b-930e-233a3b8866af2026-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA078284
rxcui: 313160
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.bf9fd9fe-095b-4478-bd2e-a5534af077612026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 313160
unii: J8BDZ68989
SumatriptanSUMATRIPTANPreferred Pharmaceuticals Inc.0b9a0ab5-d8bd-4cae-b86c-45740ee1015a2026-09-02Warnings, Adverse reactionsExact identifier
application number: ANDA078284
rxcui: 313161
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals Inc.baf37e8c-d414-4ca7-a366-97dc202372ff2026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 315223
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEMylan Pharmaceuticals Inc.1d2cd01c-05e7-44cf-a71d-0f474e826b7e2026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
SumatriptanSUMATRIPTANSportpharm LLC865865ca-01df-4815-aa7e-2dfadc2c539d2026-07-23Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATESportpharm LLC7d3602a1-1cd5-41c2-a0a3-3d20e90a92fa2026-07-09Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
sumatriptan succinateSUMATRIPTAN SUCCINATESun Pharmaceutical Industries, Inc.9485cc30-15e8-4b53-876d-db317145474b2026-06-25Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANBionpharma Inc.e90b0eea-c424-4f00-98da-6ed6e80de1f62026-05-29Warnings, Adverse reactionsExact identifier
application number: ANDA078284
ndc (product): 69452-346
rxcui: 315223
rxcui: 313160
rxcui: 313161
spl id: 4f61a0dc-b9b8-44a3-8fbf-f995a0c3931d
spl set id: e90b0eea-c424-4f00-98da-6ed6e80de1f6
unii: J8BDZ68989
SumatriptanSUMATRIPTANArmas Pharmaceuticals Inc.65147b04-0b6b-4d30-9710-d5cdce85e8f52026-05-28Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEREMEDYREPACK INC.73c9ac06-b55e-41e0-90ec-deb250f37eb52026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 313160
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEAurobindo Pharma Limitedb2503fff-c978-4efa-b1b4-d7740b6b26f22026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
SumatriptanSUMATRIPTANA-S Medication Solutions7f34f450-d6f3-49a8-b55a-8e1e4a9ee9502026-05-11Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATESportpharm LLCd071aef6-a5bd-4f68-ba6d-03004466897c2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANGolden State Medical Supply, Inc.4b4915d3-be7a-e5fa-e063-6294a90a7f982026-04-23Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEGolden State Medical Supply, Inc.1bf70380-8272-4c0d-8841-d39ef27723512026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
SUMATRIPTANSUMATRIPTANStrides Pharma Science Limited1909558d-8342-4af0-9487-eecdaac700702026-04-15Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddy's Laboratories Limitedac80d018-6abf-2e41-ddea-90b4ff9e90132026-03-21Warnings, Adverse reactionsExact identifier
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
sumatriptanSUMATRIPTANONESOURCE SPECIALTY PHARMA LIMITED587e6bb5-a665-4396-814e-ce893a20290b2026-02-20Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEA-S Medication Solutions62ba6fef-467a-4500-993c-51907f12a67c2026-02-14Warnings, Adverse reactionsExact identifier
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989

Reported adverse events (FAERS/openFDA)#

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