FDA.reportPublic FDA data

Tizanidine

Product NDC
50436-1180
11-digit product format
504361180
Labeler code
50436
Product ID
50436-1180_b0d06b9f-499b-4aa9-b1cf-65887b88b1ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076286
Marketing category
ANDA
Marketing start
2002-07-03
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
2022-12-31
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
50436-1180-12023-01-30C16284748780-1f386c649-cd84-0266-e053-dadaa90a7c1aThese 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
50436-1180-22023-01-30C16284748780-1f386c649-cd84-0266-e053-dadaa90a7c1aThese 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
50436-1180-32023-01-30C16284748780-1f386c649-cd84-0266-e053-dadaa90a7c1aThese 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
50436-1180-1Tizanidine30 in 1 BOTTLETABLET308
50436-1180-2Tizanidine60 in 1 BOTTLETABLET608
50436-1180-3Tizanidine90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1180TIZANIDINE TABLET [UNIT DOSE SERVICES]8Legacy NDC, 3 package rows20211023_9d5703f0-8d57-4c4b-8f88-45bd03fd67f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN9d5703f0-8d57-4c4b-8f88-45bd03fd67f58
313413tizanidine 4 MG Oral TabletSCD9d5703f0-8d57-4c4b-8f88-45bd03fd67f58
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY9d5703f0-8d57-4c4b-8f88-45bd03fd67f58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-1180-15043611800130 TABLET in 1 BOTTLE (50436-1180-1) 30 tablet2021-10-120000-00-00NoNoCurrent
50436-1180-25043611800260 TABLET in 1 BOTTLE (50436-1180-2) 60 tablet2021-10-120000-00-00NoNoCurrent
50436-1180-35043611800390 TABLET in 1 BOTTLE (50436-1180-3) 90 tablet2021-10-120000-00-00NoNoCurrent