FDA.reportPublic FDA data

Tizanidine

Product NDC
76420-229
11-digit product format
764200229
Labeler code
76420
Product ID
76420-229_3aa8c7f8-ee1a-be39-e063-6294a90a0e71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA076286
Marketing category
ANDA
Marketing start
2002-07-03
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412, 313413

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
76420-229-10Tizanidine10 in 1 BOTTLETABLET105
76420-229-12Tizanidine12 in 1 BOTTLETABLET125
76420-229-30Tizanidine30 in 1 BOTTLETABLET305
76420-229-60Tizanidine60 in 1 BOTTLETABLET605
76420-229-90Tizanidine90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-229-30EA - Each76420-229cc418875-83b8-4440-b795-91a06e33af8b12022-08-04
76420-229-60EA - Each76420-22964772050-c7b4-48ba-9d9b-270621f284e612022-08-04
76420-229-90EA - Each76420-2293ee0c65c-a890-4b26-80af-7bf56186c29912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-229TIZANIDINE TABLET [ASCLEMED USA, INC.]4Current NDC, Legacy NDC, 5 package rows20250330_24d8b33f-d1fb-4b4a-afbe-e2e7134dce29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313413tiZANidine HCl 4 MG Oral TabletPSN24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313412tizanidine 2 MG Oral TabletSCD24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313413tizanidine 4 MG Oral TabletSCD24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY24d8b33f-d1fb-4b4a-afbe-e2e7134dce295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-229-107642002291010 TABLET in 1 BOTTLE (76420-229-10) 10 tablet2024-01-09NoNoHistorical
76420-229-127642002291212 TABLET in 1 BOTTLE (76420-229-12) 12 tablet2025-07-24NoNoHistorical
76420-229-307642002293030 TABLET in 1 BOTTLE (76420-229-30) 30 tablet2022-07-070000-00-00NoNoCurrent
76420-229-607642002296060 TABLET in 1 BOTTLE (76420-229-60) 60 tablet2022-07-070000-00-00NoNoCurrent
76420-229-907642002299090 TABLET in 1 BOTTLE (76420-229-90) 90 tablet2022-07-070000-00-00NoNoCurrent