FDA.reportPublic FDA data

Tizanidine HCL

Product NDC
80425-0024
11-digit product format
804250024
Labeler code
80425
Product ID
80425-0024_2a984dd9-7291-77f0-e063-6294a90a8f1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA091283
Marketing category
ANDA
Marketing start
2013-04-01
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
80425-0024-1Tizanidine HCL60 in 1 BOTTLETABLET607
80425-0024-2Tizanidine HCL90 in 1 BOTTLETABLET907
80425-0024-3Tizanidine HCL30 in 1 BOTTLETABLET307
80425-0024-4Tizanidine HCL120 in 1 BOTTLETABLET1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0024-1EA - Each80425-0024e8f5f971-d157-4d2b-a47b-1ec9117525a012023-06-06
80425-0024-2EA - Each80425-00244a98ef07-fc68-4c27-b337-9790758ecbb512023-06-06
80425-0024-3EA - Each80425-002483743047-b185-468b-96eb-4168202d005912023-06-06
80425-0024-4EA - Each80425-002431c4a377-677a-4398-9b7c-88c3f89dadb212023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0024TIZANIDINE HCL TABLET [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 4 package rows20250101_afc96ee6-c99b-7283-e053-2a95a90ad14d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNafc96ee6-c99b-7283-e053-2a95a90ad14d7
313413tizanidine 4 MG Oral TabletSCDafc96ee6-c99b-7283-e053-2a95a90ad14d7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYafc96ee6-c99b-7283-e053-2a95a90ad14d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0024-18042500240160 TABLET in 1 BOTTLE (80425-0024-1) 60 tablet2013-04-010000-00-00NoNoCurrent
80425-0024-28042500240290 TABLET in 1 BOTTLE (80425-0024-2) 90 tablet2013-04-010000-00-00NoNoCurrent
80425-0024-38042500240330 TABLET in 1 BOTTLE (80425-0024-3) 30 tablet2013-04-010000-00-00NoNoCurrent
80425-0024-480425002404120 TABLET in 1 BOTTLE (80425-0024-4) 120 tablet2023-03-31NoNoCurrent