FDA.reportPublic FDA data

NDC 80425-0208-01 - Topiramate

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
80425-0208
Requested NDC
80425-0208-01
Package NDCs from labels
80425-0208-1, 80425-0208-2, 80425-0208-3, 80425-0208-01
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
Topiramate - 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
80425-0208-1Topiramate60 in 1 BOTTLETABLET603
80425-0208-2Topiramate30 in 1 BOTTLETABLET303
80425-0208-3Topiramate90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0208TOPIRAMATE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, Legacy NDC, 3 package rows20250101_eca774cf-2e4e-7642-e053-2a95a90a847d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0208-1EA - Each80425-020851098446-252b-47dd-815c-48f7a3c9f1c412023-04-07
80425-0208-2EA - Each80425-0208f3740312-abf9-4506-b6bf-54643e59401112023-06-06
80425-0208-3EA - Each80425-0208f818edb6-3f4d-46b9-8ae8-2ab2543caeca12023-06-06

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 6 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topiramateTOPIRAMATEAdvanced Rx of Tennessee, LLC30ca2fce-4e4c-439e-e063-6294a90af0762025-03-20Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.bbf0f882-1dcc-415d-82bb-acc64f4dc2bc2025-02-21Warnings, Adverse reactionsExact identifier
rxcui: 199889
unii: 0H73WJJ391
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.288d6b40-8c87-4f16-85a7-86166b5ac77f2025-02-14Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
topiramateTOPIRAMATEAdvanced Rx of Tennessee, LLC2cf7ce9e-afc2-f94e-e063-6394a90a35d02025-01-30Warnings, Adverse reactionsExact identifier
rxcui: 199889
unii: 0H73WJJ391
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.521be3f1-3ee7-45c7-9f0c-17e08b6c8fca2025-01-21Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
TopiramateTOPIRAMATEProficient Rx LPd63b64dd-b420-4283-9bac-92ba43c9f4292025-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA076343
rxcui: 199889
unii: 0H73WJJ391
TopiramateTOPIRAMATEAdvanced Rx Pharmacy of Tennessee, LLCeca774cf-2e4e-7642-e053-2a95a90a847d2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA076343
ndc (package): 80425-0208-2
ndc (package): 80425-0208-1
ndc (package): 80425-0208-3
ndc (product): 80425-0208
ndc11 (package): 80425020801
rxcui: 199888
spl id: 2a99c0c8-93bb-9e14-e063-6394a90a332b
spl set id: eca774cf-2e4e-7642-e053-2a95a90a847d
unii: 0H73WJJ391
TopiramateTOPIRAMATEAdvanced Rx Pharmacy of Tennessee, LLCd8dff98f-185e-77ba-e053-2995a90aed2f2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA076343
rxcui: 151226
unii: 0H73WJJ391
TopiramateTOPIRAMATEAdvanced Rx Pharmacy of Tennessee, LLCf16065c0-9949-9ac4-e053-2995a90a3b022024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
TopiramateTOPIRAMATEAdvanced Rx Pharmacy of Tennessee, LLCf781ada8-f90d-b233-e053-6394a90a87ff2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
topiramateTOPIRAMATEZydus Lifesciences Limited6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b2024-10-25Exact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEA-S Medication Solutions8706a35d-5c39-4daf-b83a-65f3d630e0432024-08-21Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
TopiramateTOPIRAMATEBryant Ranch Prepack61390be3-7553-4cb5-b5da-7571ed7d4b172024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
TopiramateTOPIRAMATEBryant Ranch Prepackffaacad8-4594-45a8-b292-02a84cd0c35b2024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
TopiramateTOPIRAMATEAdvanced Rx Pharmacy of Tennessee, LLCb353e7fb-b976-96d8-e053-2995a90a110a2024-08-14Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
topiramateTOPIRAMATEZydus Lifesciences Limited57016639-89fe-43ad-89c4-5e7a756dddec2024-08-14Exact identifier
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepack654f7c48-8c5d-4b97-88d6-397696f82b6a2024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
topiramateTOPIRAMATENuCare Pharmaceuticals,Inc.1ef1c408-30f7-51ee-e063-6394a90ac8802024-08-05Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
TopiramateTOPIRAMATEBryant Ranch Prepacke9cb3c29-098c-405f-a200-b436ac7fa1a22024-07-24Warnings, Adverse reactionsExact identifier
application number: ANDA076343
rxcui: 199890
unii: 0H73WJJ391
TopiramateTOPIRAMATENuCare Pharmaceuticals, Inc.4a656a9f-8eb8-69b7-e054-00144ff8d46c2024-07-19Warnings, Adverse reactionsExact identifier
application number: ANDA076343
rxcui: 199889
unii: 0H73WJJ391

Reported adverse events (FAERS/openFDA)#

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