FDA.reportPublic FDA data

NDC 80425-0425-01 - 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
80425-0425
Requested NDC
80425-0425-01
Package NDCs from labels
80425-0425-3, 80425-0425-2, 80425-0425-1, 80425-0425-01
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
80425-0425-1Tizanidine HCl30 in 1 BOTTLETABLET309
80425-0425-2Tizanidine HCl60 in 1 BOTTLETABLET609
80425-0425-3Tizanidine HCl90 in 1 BOTTLETABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0425TIZANIDINE HCL TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, 3 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
80425-0425-1EA - Each80425-0425ecd194e3-786e-4e75-a713-571c8713811112024-09-09
80425-0425-2EA - Each80425-042528ab1880-5935-4467-9cc1-deec0793282012024-09-09
80425-0425-3EA - Each80425-04256ad7aec3-fbff-44e2-995f-69e52c64e09712024-09-09

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
application number: ANDA076286
rxcui: 313413
unii: B53E3NMY5C
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEAscend Laboratories, LLCd7c97b79-da59-4e86-a01b-f91046d04f742025-12-23Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEAsclemed USA, Inc.07b8db58-d037-477e-a62f-025e8a5afcb42025-12-18Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEZydus Lifesciences Limited5f4889d1-1387-4c90-9b76-00beda3c16832025-12-15Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.146c853c-99a8-4bf3-b1e3-be6876abe6ff2025-12-10Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidine HCLTIZANIDINE HCLAdvanced Rx of Tennessee, LLCb353cdb8-75fa-7e3c-e053-2a95a90ada582025-12-05Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidine HClTIZANIDINE HCLAdvanced Rx Pharmacy of Tennessee, LLCafc90292-c6bf-2d96-e053-2995a90abf002025-12-03Warnings, Adverse reactionsExact identifier
application number: ANDA076286
ndc (package): 80425-0425-2
ndc (package): 80425-0023-3
ndc (package): 80425-0023-4
ndc (package): 80425-0425-3
ndc (package): 80425-0023-1
ndc (package): 80425-0425-1
ndc (package): 80425-0023-2
ndc (product): 80425-0425
ndc (product): 80425-0023
ndc11 (package): 80425042501
rxcui: 313412
rxcui: 313413
spl id: 45116bd8-f15b-9af1-e063-6294a90a1144
spl set id: afc90292-c6bf-2d96-e053-2995a90abf00
unii: B53E3NMY5C
Tizanidine HCLTIZANIDINE HCLAdvanced Rx Pharmacy of Tennessee, LLCc46c7aa3-69db-82dc-e053-2995a90ac2512025-11-17Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2c2bdad9-74a5-8508-e063-6294a90aac7f2025-11-17Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEAvKAREacc8f9f6-ceb6-0505-8f11-fd7e1f105af32025-10-28Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEBryant Ranch Prepack9d127a0b-b182-4c8a-91a3-311cc936fd4c2025-10-28Warnings, Adverse reactionsExact identifier
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
rxcui: 313412
unii: B53E3NMY5C
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.fd16a25c-67b6-ae6c-e053-6394a90aeee02025-10-09Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.fdf4f09d-4537-a438-e053-6394a90a573d2025-10-09Warnings, Adverse reactionsExact identifier
rxcui: 313413
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
unii: B53E3NMY5C
tizanidineTIZANIDINEViona Pharmaceuticals Inc8ac00d59-bb80-4530-afe7-90e04a2130b22025-08-26Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEDirect_Rx0bdc188d-b895-acbc-e063-6294a90acd682025-08-19Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidineTIZANIDINERising Pharma Holdings, Inc.433ac98f-ac22-44ad-a8b4-5db5560b9d0f2025-08-14Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C

Reported adverse events (FAERS/openFDA)#

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