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 5 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tizanidineTIZANIDINENuCare Pharmaceuticals, Inc.26cffb1f-21a0-017f-e063-6394a90afb1a2025-01-14Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINENuCare Pharmaceuticals,Inc.a7470959-8943-215b-e053-2a95a90a78782025-01-10Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEIngenus Pharmaceuticals, LLC99cc8f5f-b947-4ddc-99b6-1e4cef09b7172025-01-10Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEPreferred Pharmaceuticals Inc.6e97c1ba-8171-4707-98ee-61afed75daac2025-01-02Warnings, Adverse reactionsExact identifier
application number: ANDA091283
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEAdvanced Rx of Tennessee, LLC21b7c8a8-ee07-a204-e063-6394a90a285b2025-01-01Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
Tizanidine HCLTIZANIDINE HCLAdvanced Rx of Tennessee, LLCafc96ee6-c99b-7283-e053-2a95a90ad14d2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA091283
rxcui: 313413
unii: B53E3NMY5C
Tizanidine HCLTIZANIDINE HCLAdvanced Rx of Tennessee, LLCaf73c6ab-6c1c-94d1-e053-2a95a90a4e3c2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
tizanidineTIZANIDINEAsclemed USA, Inc.a9ba9023-0c3f-4c9b-ba8e-d39d23bf35d62024-12-26Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
Tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDECadila Pharmaceuticals Limitedf2f4e117-0318-4bbd-aaa7-fab803714f212024-12-23Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ee3e9813-a738-46d1-9c05-c931aee1495c2024-12-17Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEQuality Care Products LLC87f8a776-e8ae-4aed-a221-98ca72a2bedf2024-12-16Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEQuality Care Products, LLCb68a9f81-7138-48cf-b987-b8d284e8105a2024-12-11Warnings, Adverse reactionsExact identifier
rxcui: 313412
unii: B53E3NMY5C
TizanidineTIZANIDINEDr. Reddy's Laboratories Limiteda42f3479-f2c2-8214-d547-c5cae9bfed1e2024-12-11Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
tizanidineTIZANIDINEZydus Lifesciences Limited89105a78-badb-469e-966e-195fa3a53f0a2024-12-10Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack00fcd792-18a4-45d9-9c6e-0634b54b152a2024-12-05Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidineTIZANIDINEAdvanced Rx of Tennessee, LLC2788942d-87fa-e514-e063-6294a90a09712024-11-22Warnings, Adverse reactionsExact identifier
rxcui: 313413
unii: B53E3NMY5C
TizanidineTIZANIDINEAsclemed USA, Inc.81385ce2-1d82-4987-8e18-83c823e10b992024-10-29Warnings, Adverse reactionsExact identifier
rxcui: 313412
rxcui: 313413
unii: B53E3NMY5C
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC26f8f233-5dc2-0013-e063-6394a90ab0f52024-10-29Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEAdvanced Rx Pharmacy of Tennessee, LLCd2961d1c-5de2-0a2b-e053-2995a90ad2fc2024-09-12Warnings, Adverse reactionsExact identifier
application number: ANDA091283
ndc (package): 80425-0187-2
ndc (package): 80425-0187-3
ndc (package): 80425-0187-1
ndc (product): 80425-0187
ndc11 (package): 80425018701
rxcui: 313412
spl id: 21edbe60-524e-b675-e063-6294a90ad2d6
spl set id: d2961d1c-5de2-0a2b-e053-2995a90ad2fc
unii: B53E3NMY5C
TizanidineTIZANIDINEBryant Ranch Prepacke13292b0-9858-4405-8787-a2392d1b6d752024-08-28Warnings, Adverse reactionsExact identifier
rxcui: 313412
unii: B53E3NMY5C

Reported adverse events (FAERS/openFDA)#

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