FDA.reportPublic FDA data

NDC 80425-0436-01 - Tizanidine

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
80425-0436
Requested NDC
80425-0436-01
Package NDCs from labels
80425-0436-2, 80425-0436-3, 80425-0436-1, 80425-0436-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tizanidine - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-01-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0436-1Tizanidine30 in 1 BOTTLETABLET303
80425-0436-2Tizanidine60 in 1 BOTTLETABLET603
80425-0436-3Tizanidine90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0436TIZANIDINE TABLET [ADVANCED RX OF TENNESSEE, LLC]3Current NDC, 3 package rows20250103_21b7c8a8-ee07-a204-e063-6394a90a285b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0436-1EA - Each80425-04368753fd38-5640-47e2-972a-bafa5fa82e4512024-10-04
80425-0436-2EA - Each80425-04365e314baf-47d2-46ac-b8b4-d6e8d8f947f212024-10-04
80425-0436-3EA - Each80425-0436ecc31364-2aaa-4e5b-9912-250c93505d8a12024-10-04

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 37 · 726 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack649f1f76-da33-4bdf-a38d-5ae3a9cb79872026-07-09Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEREMEDYREPACK INC.b14bd166-9f53-4f2e-be05-c447af04ef692026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
TizanidineTIZANIDINEHAWAII REPACK, INC.45de30ce-959f-4e2e-a974-6f90568139c92026-06-25Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEREMEDYREPACK INC.59084f59-9a9b-49f0-a9f4-27f3eab9a2282026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINERedpharm Drug54ade0c7-4bf0-54d4-e063-6294a90a8b172026-06-20Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINESt. Mary's Medical Park Pharmacyc6b4486f-e847-64ee-e053-2995a90a855a2026-06-19Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEDirect_Rx5460dbf8-b30d-db94-e063-6394a90a55532026-06-16Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
TizanidineTIZANIDINESt. Mary's Medical Park Pharmacycfd52c0c-a7c2-e23d-e053-2a95a90abbd12026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 313412
unii: B53E3NMY5C
tizanidineTIZANIDINEMajor Pharmaceuticalsd24e0cda-a22f-404f-b861-f85090cef0992026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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