FDA.reportPublic FDA data

Tizanidine HCL

Product NDC
80425-0022
11-digit product format
804250022
Labeler code
80425
Product ID
80425-0022_2a987b85-efd6-eb95-e063-6394a90aef81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA076416
Marketing category
ANDA
Marketing start
2003-12-11
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
Rxcui313413

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
80425-0022-1Tizanidine HCL60 in 1 BOTTLETABLET606
80425-0022-2Tizanidine HCL90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0022-1EA - Each80425-0022add5c82f-6c8a-48e1-84a7-707cd9bc8ff812023-06-06
80425-0022-2EA - Each80425-00226e887858-2ea9-4fb2-aec2-2d39608f538112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0022TIZANIDINE HCL TABLET [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_af73c6ab-6c1c-94d1-e053-2a95a90a4e3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNaf73c6ab-6c1c-94d1-e053-2a95a90a4e3c6
313413tizanidine 4 MG Oral TabletSCDaf73c6ab-6c1c-94d1-e053-2a95a90a4e3c6
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYaf73c6ab-6c1c-94d1-e053-2a95a90a4e3c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0022-18042500220160 TABLET in 1 BOTTLE (80425-0022-1) 60 tablet2003-12-110000-00-00NoNoCurrent
80425-0022-28042500220290 TABLET in 1 BOTTLE (80425-0022-2) 90 tablet2003-12-110000-00-00NoNoCurrent