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 3 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rxf6c95873-576d-a1c2-e053-6294a90a3ff92025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 315223
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rxf6c907a3-9624-f893-e053-6294a90a31af2025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 313161
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.7628caf4-5272-4e42-e053-2a91aa0a2f242025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 313161
unii: J8BDZ68989
SumatriptanSUMATRIPTANProficient Rx LP85bf8e58-0984-427b-9ed4-7e0df4e444d22025-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA078284
rxcui: 313161
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2a96f37d-03f6-678c-e063-6394a90ae0c62024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 313160
unii: J8BDZ68989
SumatriptanSUMATRIPTANAdvanced Rx of Tennessee, LLCf1a118cf-2179-572a-e053-2995a90acbb02024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 313160
unii: J8BDZ68989
SumatriptanSUMATRIPTANAdvanced Rx Pharmacy of Tennessee, LLCf27ca3c0-9de0-ff9c-e053-2a95a90ab8942024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA078284
ndc (package): 80425-0258-1
ndc (product): 80425-0258
ndc11 (package): 80425025801
rxcui: 313160
spl id: 2a9ba8f4-6ce4-e827-e063-6394a90a0300
spl set id: f27ca3c0-9de0-ff9c-e053-2a95a90ab894
unii: J8BDZ68989
SumatriptanSUMATRIPTANAdvanced Rx of Tennessee, LLC2aab8786-b225-833a-e063-6394a90ac7ae2024-12-30Warnings, Adverse reactionsExact identifier
application number: ANDA078284
rxcui: 313161
unii: J8BDZ68989
Sumatriptan Succinate and Naproxen SodiumSUMATRIPTAN SUCCINATE AND NAPROXEN SODIUMCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven5762bbe6-bddf-495c-adf8-9096f98a3a9c2024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
TreximetSUMATRIPTAN SUCCINATE AND NAPROXEN SODIUMCurrax Pharmaceuticals LLC42ddf376-8dc0-4236-be2a-0c6ae92ece042024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLC5d1f3de0-684a-4092-be30-aa325ff20d042024-12-18Warnings, Adverse reactionsExact identifier
rxcui: 313160
unii: J8BDZ68989
MigranowSUMATRIPTAN SUCCINATE, CAMPHOR, MENTHOLPureTek Corporationb82d7d65-9ef4-4f05-9a7d-10440683332e2024-12-13Warnings, Adverse reactionsExact identifier
rxcui: 313161
Sumatriptan and Naproxen SodiumSUMATRIPTAN AND NAPROXEN SODIUMAurobindo Pharma Limitedf5203c66-0a40-4263-a237-b71e930e46972024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rx284ee7ac-759e-b592-e063-6394a90a78ba2024-12-02Warnings, Adverse reactionsExact identifier
application number: ANDA078284
rxcui: 315223
unii: J8BDZ68989
SumatriptanSUMATRIPTANA-S Medication Solutions790acc89-81b3-4869-92e7-dc9f7fa6567b2024-11-08Warnings, Adverse reactionsExact identifier
application number: ANDA078284
rxcui: 315223
unii: J8BDZ68989
SumatriptanSUMATRIPTANCaplin Steriles Limited01293e09-d49a-411d-9647-6f23318ac2012024-09-28Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
SumatriptanSUMATRIPTANAdvanced Rx Pharmacy of Tennessee, LLCf8c4bbfb-1586-4610-e053-6394a90a8f092024-08-27Warnings, Adverse reactionsExact identifier
rxcui: 313161
unii: J8BDZ68989
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.b297a466-7d24-9ebd-e053-2a95a90af4d12024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 313160
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.54c6f8f4-5466-3988-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
rxcui: 313161
unii: J8BDZ68989
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.933f6575-a4c4-0f65-e053-2a95a90ab9672024-06-19Exact identifier
rxcui: 313160
unii: J8BDZ68989

Reported adverse events (FAERS/openFDA)#

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