FDA.reportPublic FDA data

Tizanidine HCL

Product NDC
80425-0144
11-digit product format
804250144
Labeler code
80425
Product ID
80425-0144_43cfb518-01fc-0ea4-e063-6394a90a06d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA212196
Marketing category
ANDA
Marketing start
2019-03-29
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485485

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0ff02d8-b711-423c-b7d1-ada00d81c743Product name120250805
9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01Product name820250313
b404127e-1c01-47bb-874e-db1e0b6bd9afProduct name420250313

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485485tiZANidine HCl 4 MG Oral CapsulePSNc46c7aa3-69db-82dc-e053-2995a90ac2519
485485tizanidine 4 MG Oral CapsuleSCDc46c7aa3-69db-82dc-e053-2995a90ac2519
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYc46c7aa3-69db-82dc-e053-2995a90ac2519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0144-18042501440130 CAPSULE in 1 BOTTLE (80425-0144-1) 30 capsule2019-03-290000-00-00NoNoCurrent
80425-0144-28042501440260 CAPSULE in 1 BOTTLE (80425-0144-2) 60 capsule2019-03-290000-00-00NoNoCurrent
80425-0144-38042501440390 CAPSULE in 1 BOTTLE (80425-0144-3) 90 capsule2019-03-290000-00-00NoNoCurrent
80425-0144-480425014404120 CAPSULE in 1 BOTTLE (80425-0144-4) 120 capsule2025-11-17NoNoHistorical