FDA.reportPublic FDA data

NDC 80425-0144-01 - 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
80425-0144
Requested NDC
80425-0144-01
Package NDCs from labels
80425-0144-3, 80425-0144-2, 80425-0144-1, 80425-0144-4, 80425-0144-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2025-11-17
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, LLC2025-11-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0144-1Tizanidine HCL30 in 1 BOTTLECAPSULE309
80425-0144-2Tizanidine HCL60 in 1 BOTTLECAPSULE609
80425-0144-3Tizanidine HCL90 in 1 BOTTLECAPSULE909
80425-0144-4Tizanidine HCL120 in 1 BOTTLECAPSULE1209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0144TIZANIDINE HCL CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 4 package rows20250101_c46c7aa3-69db-82dc-e053-2995a90ac251.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0144-1EA - Each80425-0144b99d8b6e-963c-4879-8b61-3267b63e9b1912023-06-06
80425-0144-2EA - Each80425-01442c88d83a-8c4b-4926-80b5-8419ee8e0ed412023-06-06
80425-0144-3EA - Each80425-01444ef89d59-832a-4d98-ae18-e74972a19a0212023-06-06
80425-0144-4EA - Each80425-014435e993ff-b889-457e-a09e-a02fbef0a6ca12025-12-16

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 4 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TizanidineTIZANIDINEAsclemed USA, Inc.24d8b33f-d1fb-4b4a-afbe-e2e7134dce292025-07-24Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEPHOENIX RX LLC3a7b9b9a-9bf9-0b37-e063-6294a90a1c392025-07-21Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.615dfd5c-125a-40e2-a6da-afacde3052822025-07-17Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEUnichem Pharmaceuticals (USA), Inc.a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb2025-05-27Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEAmerican Health Packaging3670f9e3-988d-48e6-9df0-d403d699e08a2025-05-22Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEBryant Ranch Prepack73269d77-16b5-4787-9a7d-1b86886234362025-05-22Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
ZanaflexTIZANIDINE HYDROCHLORIDECovis Pharma US, Inc043d9e51-bfa2-4add-9058-5ece332f7e992025-05-05Warnings, Adverse reactionsExact identifier
rxcui: 485485
rxcui: 485486
rxcui: 485484
unii: B53E3NMY5C
TizanidineTIZANIDINEAsclemed USA, Inc.2f460275-565f-4737-a3df-bf80b9acc2682025-05-02Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEA-S Medication Solutions9678a98e-4aab-4d87-b5e1-37c3109e378e2025-04-02Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidineTIZANIDINEAdvanced Rx of Tennessee, LLC30caf3b3-8c1b-268e-e063-6294a90a3c8a2025-03-20Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEBryant Ranch Prepackf87e30ce-a60a-41e3-b5d6-7e29661439612025-02-19Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidineTIZANIDINECoupler LLC2d9a2492-d914-f87b-e063-6394a90a38c62025-02-07Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINENuCare Pharmaceuticals,Inc.fe2f5064-0b7c-d03d-e053-6294a90a96042025-02-04Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEDirect_rx2a91884a-39c3-f7ac-e063-6394a90ade142025-02-03Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEProficient Rx LPc2353d09-3cb4-486e-8ae7-29339c1ba76b2025-02-01Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidineTIZANIDINEAphena Pharma Solutions - Tennessee, LLCef7673f4-e0c1-4d79-af36-2f2ed2cc28f72025-01-29Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEModavar Pharmaceuticals LLCf8288ccd-6c66-415e-a06b-758971afe9a02025-01-29Warnings, Adverse reactionsExact identifier
rxcui: 485485
rxcui: 485486
rxcui: 485484
unii: B53E3NMY5C
TizanidineTIZANIDINENorthStar Rx LLCeed74219-9d4a-fecd-1bb9-ad6c01ad3e9d2025-01-27Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEBryant Ranch Prepack58c10b87-004e-4d2d-b5c1-b353c2cd071f2025-01-24Warnings, Adverse reactionsExact identifier
rxcui: 485485
unii: B53E3NMY5C
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEAurobindo Pharma Limited19cf46b5-d8dc-44cb-83d6-bacea0870dbe2025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 485485
rxcui: 485486
rxcui: 485484
unii: B53E3NMY5C

Reported adverse events (FAERS/openFDA)#

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