FDA.reportPublic FDA data

NDC 80425-0187-01 - 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
80425-0187
Requested NDC
80425-0187-01
Package NDCs from labels
80425-0187-1, 80425-0187-2, 80425-0187-3, 80425-0187-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-09-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tizanidine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-09-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0187-1Tizanidine30 in 1 BOTTLETABLET305
80425-0187-2Tizanidine60 in 1 BOTTLETABLET605
80425-0187-3Tizanidine90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0187TIZANIDINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 3 package rows20240913_d2961d1c-5de2-0a2b-e053-2995a90ad2fc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0187-1EA - Each80425-01871974c522-2406-4ece-90e7-1c4a1e6eba4c12023-04-07
80425-0187-2EA - Each80425-0187dfa9dda2-4278-4ecf-b9c2-418d29a000be12023-06-06
80425-0187-3EA - Each80425-0187a6a50647-5074-4a52-92a9-5587fef9789f12023-06-06

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 2 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEKanchan Healthcare Inc22ea819a-2aaa-44e0-a350-258541b112202026-04-08Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEREMEDYREPACK INC.f041e5f7-c138-4622-98bf-881f9a649a262026-04-06Warnings, Adverse reactionsExact identifier
rxcui: 313412
unii: B53E3NMY5C
TizanidineTIZANIDINEREMEDYREPACK INC.7bbc81e5-ad3e-496b-908f-e6f500f6ad7e2026-04-03Warnings, Adverse reactionsExact identifier
rxcui: 313412
unii: B53E3NMY5C
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack31b40276-099b-482c-a13c-8fbbf1ebc50a2026-03-25Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack04febb37-00d6-4279-8c5f-171950278c8f2026-03-25Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack3288d98d-aa49-4a36-a6d9-703645d8bcd72026-03-25Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEDirect_rx29a275f9-de6b-ee63-e063-6294a90aba282026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 313412
unii: B53E3NMY5C
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE047c67cd-7a63-49c9-b100-71651d3537ba2026-03-05Warnings, Adverse reactionsExact identifier
application number: ANDA091283
rxcui: 313413
unii: B53E3NMY5C
TIZANDINETIZANDINEDirect_Rx9003cb5d-f9d6-7183-e053-2995a90ad6e82026-03-05Warnings, Adverse reactionsExact identifier
application number: ANDA091283
rxcui: 313412
unii: B53E3NMY5C
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDETrifluent Pharma, LLC4a2cf456-58c5-c26d-e063-6294a90a0b242026-02-27Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEA-S Medication Solutions308d2fdc-6136-4e75-95d3-342497add66c2026-02-13Warnings, Adverse reactionsExact identifier
application number: ANDA091283
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEA-S Medication Solutions9fd932fb-033c-4774-ac09-c823db8f97392026-02-12Warnings, Adverse reactionsExact identifier
application number: ANDA091283
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEBryant Ranch Prepackfefe8332-32eb-4b81-978f-b23b334d7d572026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINERedpharm Drug49adcfc8-3b1d-7f7e-e063-6294a90a361e2026-01-31Warnings, Adverse reactionsExact identifier
application number: ANDA091283
rxcui: 313412
unii: B53E3NMY5C
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEPreferred Pharmaceuticals Inc.3f569c5a-ec9d-4356-ac04-c17714ff68d12026-01-23Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ebccdb33-2b3c-4071-9765-8d95bcbc9b5f2026-01-21Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEAvPAKb694225c-1fa9-4726-89a6-fd3f870842482026-01-11Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.ac897a5a-677b-4a6e-abb1-b810470200fc2026-01-07Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
ZanaflexTIZANIDINE HYDROCHLORIDELegacy Pharma USA, Inc.60c27d35-7349-4fc6-86ad-70fffdbe3e082026-01-02Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINENorthwind Health Company, LLCf32f399f-42af-f0ba-e053-2a95a90a8c2e2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C

Reported adverse events (FAERS/openFDA)#

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