FDA.reportPublic FDA data

NDC 80425-0023-01 - Tizanidine HCl

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
80425-0023
Requested NDC
80425-0023-01
Package NDCs from labels
80425-0023-2, 80425-0023-1, 80425-0023-3, 80425-0023-4, 80425-0023-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2025-12-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tizanidine HCl - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2025-12-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0023-1Tizanidine HCl60 in 1 BOTTLETABLET609
80425-0023-2Tizanidine HCl90 in 1 BOTTLETABLET909
80425-0023-3Tizanidine HCl30 in 1 BOTTLETABLET309
80425-0023-4Tizanidine HCl120 in 1 BOTTLETABLET1209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0023TIZANIDINE HCL TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 4 package rows20240807_afc90292-c6bf-2d96-e053-2995a90abf00.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0023-1EA - Each80425-0023cec684c6-cbd2-4954-ab02-75855698c35c12023-06-06
80425-0023-2EA - Each80425-0023d654c5b0-885b-4588-9bf5-31009d5f4ea212023-06-06
80425-0023-3EA - Each80425-00232b1fb47e-7f4d-4c29-9bcc-3bcd8869b68512024-06-10
80425-0023-4EA - Each80425-0023f8f2babf-e865-4633-9daa-4dcae279d96712026-01-08

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 7 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TizanidineTIZANIDINEProficient Rx LP76dc85bd-3cde-4940-a99b-663b70bf9f542022-03-01Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEBryant Ranch Prepackb254a0f4-efb1-4874-ae45-1dc5fe3169642021-12-27Warnings, Adverse reactionsExact identifier
application number: ANDA076286
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEBryant Ranch Prepack82084f4e-00d0-c298-c13a-88a6c0860b022021-12-08Warnings, Adverse reactionsExact identifier
application number: ANDA076286
rxcui: 313412
unii: B53E3NMY5C
TizanidineTIZANIDINEProficient Rx LP20424d92-5ca1-4114-bc51-1f07c3bed6be2021-03-01Warnings, Adverse reactionsExact identifier
rxcui: 313412
unii: B53E3NMY5C
TizanidineTIZANIDINESun Pharmaceutical Industries, Inc.4659df31-8b89-4eff-9d86-7b7e38de416b2020-10-09Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
tizanidineTIZANIDINEAphena Pharma Solutions - Tennessee, LLCd3b8d863-d13d-467c-97bf-5db9708036db2020-08-28Warnings, Adverse reactionsExact identifier
rxcui: 313412
unii: B53E3NMY5C
TizanidineTIZANIDINEAphena Pharma Solutions - Tennessee, LLCea242c7d-b101-4197-8e65-b2b079e3b2b62019-02-11Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C

Reported adverse events (FAERS/openFDA)#

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