FDA.reportPublic FDA data

NDC 80425-0475-01 - 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
80425-0475
Requested NDC
80425-0475-01
Package NDCs from labels
80425-0475-1, 80425-0475-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sumatriptan - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0475-1Sumatriptan9 in 1 BLISTER PACKTABLET, FILM COATED91
80425-0475-1Sumatriptan1 in 1 CARTONTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0475SUMATRIPTAN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 2 package rows20250103_2aab8786-b225-833a-e063-6394a90ac7ae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0475-1EA - Each80425-0475fc6dda65-8bf6-41f1-a0e3-e4499582e1b512025-02-10

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 70 of 123 · 2,456 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0127f290-8c5e-4285-e063-6294a90ae1282025-08-06WarningsExact identifier
unii: 15FIX9V2JP
GR BB SPF 25OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI3b22579b-21ce-4b96-bd24-774ce35bf6f72025-08-06WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 08W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L498bf941-67f2-41d5-a039-9f827b68297e2025-08-05WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 10N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L54e390bd-b84a-4c43-986e-74923e34689d2025-08-05WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 09C Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L897024cd-576e-4a8e-8daa-92dc3bb4b3a52025-08-05WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 11W Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L303967d1-9df8-4a8e-a264-6b0d8fdbf2a82025-08-05WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 12N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L26062cd7-3817-46c7-b65f-92cd57eca5dd2025-08-05WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 13C Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L448a24a3-91ef-4530-828c-e77d8aae7f0b2025-08-05WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 02C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L09f9e59b-6f71-4d42-9b5d-275f756d985b2025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 03W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3b1e4480-8409-425e-b98d-eb4dcf2471e82025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 06W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3090422e-fc18-45b8-88f2-6a9b282a72052025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 05N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf93aa5d2-90ab-4e11-874e-2ede4b25c4b62025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 04C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf055cd51-7b1d-43df-8990-8f60ba1eb91c2025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 07N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Ld4c76bc5-205b-45fd-8a02-4f4b174585032025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2bf501-fd81-6ffa-e063-6394a90afe422025-07-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2cf6fd-72cb-fa53-e063-6394a90a674a2025-07-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: B697894SGQ
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: B697894SGQ
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: B697894SGQ
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC003123d2-9675-fdd2-e063-6294a90a01302025-07-28WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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