FDA.reportPublic FDA data

tizanidine

Product NDC
50436-0252
11-digit product format
504360252
Labeler code
50436
Product ID
50436-0252_94a44a05-8615-4f00-a38d-db8a8ddf60e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076533
Marketing category
ANDA
Marketing start
2004-01-16
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
50436-0252-12021-01-29C16284748780-1ba0f9c33-4158-a910-e053-dadaa90a0b85These 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
50436-0252-22021-01-29C16284748780-1ba0f9c33-4158-a910-e053-dadaa90a0b85These 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
50436-0252-32021-01-29C16284748780-1ba0f9c33-4158-a910-e053-dadaa90a0b85These 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
50436-0252-42021-01-29C16284748780-1ba0f9c33-4158-a910-e053-dadaa90a0b85These 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
50436-0252-1tizanidine30 in 1 BOTTLETABLET304
50436-0252-2tizanidine60 in 1 BOTTLETABLET604
50436-0252-3tizanidine90 in 1 BOTTLETABLET904
50436-0252-4tizanidine120 in 1 BOTTLETABLET1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0252TIZANIDINE TABLET [UNIT DOSE SERVICES]4Legacy NDC, 4 package rows20171213_95c5c9b1-43fe-488d-898b-76663f14768a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN95c5c9b1-43fe-488d-898b-76663f14768a4
313413tiZANidine HCl 4 MG Oral TabletPSN95c5c9b1-43fe-488d-898b-76663f14768a4
313412tizanidine 2 MG Oral TabletSCD95c5c9b1-43fe-488d-898b-76663f14768a4
313413tizanidine 4 MG Oral TabletSCD95c5c9b1-43fe-488d-898b-76663f14768a4
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY95c5c9b1-43fe-488d-898b-76663f14768a4
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY95c5c9b1-43fe-488d-898b-76663f14768a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0252-15043602520130 in 1 BOTTLEHistorical
50436-0252-25043602520260 in 1 BOTTLEHistorical
50436-0252-35043602520390 in 1 BOTTLEHistorical
50436-0252-450436025204120 in 1 BOTTLEHistorical