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 3 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TizanidineTIZANIDINENorthwind Health Company, LLCda31fbeb-3781-5e75-e053-2a95a90adb732026-01-01Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEAscend Laboratories, LLCd7c97b79-da59-4e86-a01b-f91046d04f742025-12-23Warnings, Adverse reactionsExact identifier
application number: ANDA212196
ndc (product): 67877-611
rxcui: 485485
rxcui: 485486
rxcui: 485484
spl id: 628c23e5-c9ed-453b-a83e-1514d6b02912
spl set id: d7c97b79-da59-4e86-a01b-f91046d04f74
unii: B53E3NMY5C
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEAsclemed USA, Inc.07b8db58-d037-477e-a62f-025e8a5afcb42025-12-18Warnings, Adverse reactionsExact identifier
application number: ANDA212196
rxcui: 485485
rxcui: 485486
rxcui: 485484
unii: B53E3NMY5C
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEZydus Lifesciences Limited5f4889d1-1387-4c90-9b76-00beda3c16832025-12-15Warnings, Adverse reactionsExact identifier
rxcui: 485485
rxcui: 485486
rxcui: 485484
unii: B53E3NMY5C
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.146c853c-99a8-4bf3-b1e3-be6876abe6ff2025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 485485
rxcui: 485486
rxcui: 485484
unii: B53E3NMY5C
Tizanidine HCLTIZANIDINE HCLAdvanced Rx of Tennessee, LLCb353cdb8-75fa-7e3c-e053-2a95a90ada582025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 485485
unii: B53E3NMY5C
Tizanidine HClTIZANIDINE HCLAdvanced Rx Pharmacy of Tennessee, LLCafc90292-c6bf-2d96-e053-2995a90abf002025-12-03Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidine HCLTIZANIDINE HCLAdvanced Rx Pharmacy of Tennessee, LLCc46c7aa3-69db-82dc-e053-2995a90ac2512025-11-17Warnings, Adverse reactionsExact identifier
application number: ANDA212196
ndc (package): 80425-0144-3
ndc (package): 80425-0144-4
ndc (package): 80425-0144-1
ndc (package): 80425-0144-2
ndc (product): 80425-0144
ndc11 (package): 80425014401
rxcui: 485485
spl id: 43cfb518-01fc-0ea4-e063-6394a90a06d3
spl set id: c46c7aa3-69db-82dc-e053-2995a90ac251
unii: B53E3NMY5C
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2c2bdad9-74a5-8508-e063-6294a90aac7f2025-11-17Warnings, Adverse reactionsExact identifier
rxcui: 485485
unii: B53E3NMY5C
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEAvKAREacc8f9f6-ceb6-0505-8f11-fd7e1f105af32025-10-28Warnings, Adverse reactionsExact identifier
rxcui: 485485
rxcui: 485486
rxcui: 485484
unii: B53E3NMY5C
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEBryant Ranch Prepack9d127a0b-b182-4c8a-91a3-311cc936fd4c2025-10-28Warnings, Adverse reactionsExact identifier
rxcui: 485484
unii: B53E3NMY5C
OntralfyTIZANIDINE HYDROCHLORIDERosemont Pharmaceuticals, LLC7b88c338-c0b7-4c08-bef6-a4ffc2f25df72025-10-25Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidineTIZANIDINEA-S Medication Solutions52830423-0430-410e-93af-169dc11b35652025-10-17Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.fd16a25c-67b6-ae6c-e053-6394a90aeee02025-10-09Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.fdf4f09d-4537-a438-e053-6394a90a573d2025-10-09Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
ZanaflexTIZANIDINE HYDROCHLORIDETrifluent Pharma, LLC9833a1b8-f530-4a06-bc77-7d11b6e94c652025-09-30Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY4009c6cb-c183-2165-e063-6294a90aed782025-09-30Warnings, Adverse reactionsExact identifier
rxcui: 485484
unii: B53E3NMY5C
tizanidineTIZANIDINEViona Pharmaceuticals Inc8ac00d59-bb80-4530-afe7-90e04a2130b22025-08-26Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEDirect_Rx0bdc188d-b895-acbc-e063-6294a90acd682025-08-19Warnings, Adverse reactionsExact identifier
rxcui: 485484
unii: B53E3NMY5C
tizanidineTIZANIDINERising Pharma Holdings, Inc.433ac98f-ac22-44ad-a8b4-5db5560b9d0f2025-08-14Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C

Reported adverse events (FAERS/openFDA)#

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