FDA.reportPublic FDA data

Tizanidine

Product NDC
68071-5268
11-digit product format
680715268
Labeler code
68071
Product ID
68071-5268_2b622662-d79c-cce4-e063-6294a90a88ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5268-32022-02-07C16284748780-1d6a99b39-5a2c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
68071-5268-32022-01-28C16284748780-1d6a99b39-5a2c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5268-3Tizanidine30 in 1 BOTTLETABLET307
68071-5268-5Tizanidine15 in 1 BOTTLETABLET157
68071-5268-9Tizanidine90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5268TIZANIDINE TABLET [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 3 package rows20250112_a7470959-8943-215b-e053-2a95a90a7878.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNa7470959-8943-215b-e053-2a95a90a78787
313413tizanidine 4 MG Oral TabletSCDa7470959-8943-215b-e053-2a95a90a78787
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYa7470959-8943-215b-e053-2a95a90a78787

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5268-36807152680330 TABLET in 1 BOTTLE (68071-5268-3) 30 tablet2020-06-040000-00-00NoNoCurrent
68071-5268-56807152680515 TABLET in 1 BOTTLE (68071-5268-5) 15 tablet2022-07-210000-00-00NoNoCurrent
68071-5268-96807152680990 TABLET in 1 BOTTLE (68071-5268-9) 90 tablet2022-07-210000-00-00NoNoCurrent