FDA.reportPublic FDA data

NDC 80425-0090-01 - 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
80425-0090
Requested NDC
80425-0090-01
Package NDCs from labels
80425-0090-2, 80425-0090-1, 80425-0090-3, 80425-0090-4, 80425-0090-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tizanidine HCL - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-12-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0090-1Tizanidine HCL60 in 1 BOTTLECAPSULE608
80425-0090-2Tizanidine HCL90 in 1 BOTTLECAPSULE908
80425-0090-3Tizanidine HCL30 in 1 BOTTLECAPSULE308
80425-0090-4Tizanidine HCL120 in 1 BOTTLECAPSULE1208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0090TIZANIDINE HCL CAPSULE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 4 package rows20250101_b353cdb8-75fa-7e3c-e053-2a95a90ada58.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0090-1EA - Each80425-0090fdad67c7-6325-4192-bb88-fe96fbc7804f12023-06-06
80425-0090-2EA - Each80425-0090fa1bee89-d9e8-4b98-9628-f492a2a9d1fa12023-06-06
80425-0090-3EA - Each80425-0090e9da92fe-d9ce-470f-8050-3e64530dc59d12023-04-07
80425-0090-4EA - Each80425-0090cb2031ff-544d-4cad-90a8-d29c6dc5b0b512026-01-08

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
unii: B53E3NMY5C
TizanidineTIZANIDINENuCare Pharmaceuticals,Inc.a7470959-8943-215b-e053-2a95a90a78782025-01-10Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEIngenus Pharmaceuticals, LLC99cc8f5f-b947-4ddc-99b6-1e4cef09b7172025-01-10Warnings, Adverse reactionsExact identifier
application number: ANDA210267
ndc (product): 50742-225
rxcui: 485485
rxcui: 485486
rxcui: 485484
spl id: 6b60abcf-1c7f-42f4-85df-1d80fed36d54
spl set id: 99cc8f5f-b947-4ddc-99b6-1e4cef09b717
unii: B53E3NMY5C
TizanidineTIZANIDINEPreferred Pharmaceuticals Inc.6e97c1ba-8171-4707-98ee-61afed75daac2025-01-02Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEAdvanced Rx of Tennessee, LLC21b7c8a8-ee07-a204-e063-6394a90a285b2025-01-01Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidine HCLTIZANIDINE HCLAdvanced Rx of Tennessee, LLCafc96ee6-c99b-7283-e053-2a95a90ad14d2024-12-31Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidine HCLTIZANIDINE HCLAdvanced Rx of Tennessee, LLCaf73c6ab-6c1c-94d1-e053-2a95a90a4e3c2024-12-31Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidineTIZANIDINEAsclemed USA, Inc.a9ba9023-0c3f-4c9b-ba8e-d39d23bf35d62024-12-26Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDECadila Pharmaceuticals Limitedf2f4e117-0318-4bbd-aaa7-fab803714f212024-12-23Warnings, Adverse reactionsExact identifier
rxcui: 485485
rxcui: 485486
rxcui: 485484
unii: B53E3NMY5C
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ee3e9813-a738-46d1-9c05-c931aee1495c2024-12-17Warnings, Adverse reactionsExact identifier
rxcui: 485485
rxcui: 485486
rxcui: 485484
unii: B53E3NMY5C
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEQuality Care Products LLC87f8a776-e8ae-4aed-a221-98ca72a2bedf2024-12-16Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEQuality Care Products, LLCb68a9f81-7138-48cf-b987-b8d284e8105a2024-12-11Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEDr. Reddy's Laboratories Limiteda42f3479-f2c2-8214-d547-c5cae9bfed1e2024-12-11Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
tizanidineTIZANIDINEZydus Lifesciences Limited89105a78-badb-469e-966e-195fa3a53f0a2024-12-10Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack00fcd792-18a4-45d9-9c6e-0634b54b152a2024-12-05Warnings, Adverse reactionsExact identifier
rxcui: 485485
unii: B53E3NMY5C
tizanidineTIZANIDINEAdvanced Rx of Tennessee, LLC2788942d-87fa-e514-e063-6294a90a09712024-11-22Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEAsclemed USA, Inc.81385ce2-1d82-4987-8e18-83c823e10b992024-10-29Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC26f8f233-5dc2-0013-e063-6394a90ab0f52024-10-29Warnings, Adverse reactionsExact identifier
application number: ANDA210267
rxcui: 485484
unii: B53E3NMY5C
TizanidineTIZANIDINEAdvanced Rx Pharmacy of Tennessee, LLCd2961d1c-5de2-0a2b-e053-2995a90ad2fc2024-09-12Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C
TizanidineTIZANIDINEBryant Ranch Prepacke13292b0-9858-4405-8787-a2392d1b6d752024-08-28Warnings, Adverse reactionsExact identifier
unii: B53E3NMY5C

Reported adverse events (FAERS/openFDA)#

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