FDA.reportPublic FDA data

Tizanidine

Product NDC
63629-3209
11-digit product format
636293209
Labeler code
63629
Product ID
63629-3209_82084f4e-00d0-c298-c13a-88a6c0860b02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076286
Marketing category
ANDA
Marketing start
2002-07-03
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
2 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 HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412

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
63629-3209-12022-01-04C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-22022-01-04C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-32022-01-04C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-42022-01-04C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-52022-01-04C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-62022-01-04C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-72022-01-04C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-82022-01-04C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-92022-01-04C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-12020-01-31C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-22020-01-31C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-32020-01-31C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-42020-01-31C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-52020-01-31C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-62020-01-31C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-72020-01-31C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-82020-01-31C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-92020-01-31C16284748780-19d75b9d0-8bcf-f424-e053-dadaa90a57ceThese 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
63629-3209-0Tizanidine40 in 1 BOTTLETABLET404
63629-3209-1Tizanidine30 in 1 BOTTLETABLET304
63629-3209-2Tizanidine60 in 1 BOTTLETABLET604
63629-3209-3Tizanidine90 in 1 BOTTLETABLET904
63629-3209-4Tizanidine120 in 1 BOTTLETABLET1204
63629-3209-5Tizanidine100 in 1 BOTTLETABLET1004
63629-3209-6Tizanidine84 in 1 BOTTLETABLET844
63629-3209-7Tizanidine28 in 1 BOTTLETABLET284
63629-3209-8Tizanidine21 in 1 BOTTLETABLET214
63629-3209-9Tizanidine160 in 1 BOTTLETABLET1604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3209-1EA - Each63629-320994755468-7210-4cee-b98c-89f09f32693112012-07-24
63629-3209-2EA - Each63629-32094aa59f0a-130d-4d1e-8a57-022bef73733512012-07-24
63629-3209-3EA - Each63629-32094c77db4e-b653-4e2e-b251-20b78df0b22a12012-07-24
63629-3209-4EA - Each63629-32098db8bbac-e0cd-474d-bde5-339eef463e9612012-07-24
63629-3209-5EA - Each63629-320965add7e8-b489-4bb2-ab82-23bb1a651c9e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [BRYANT RANCH PREPACK]1
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [BRYANT RANCH PREPACK]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [BRYANT RANCH PREPACK]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [BRYANT RANCH PREPACK]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [BRYANT RANCH PREPACK]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [BRYANT RANCH PREPACK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3209TIZANIDINE TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20220104_82084f4e-00d0-c298-c13a-88a6c0860b02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN82084f4e-00d0-c298-c13a-88a6c0860b024
313412tizanidine 2 MG Oral TabletSCD82084f4e-00d0-c298-c13a-88a6c0860b024
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY82084f4e-00d0-c298-c13a-88a6c0860b024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3209-06362932090040 TABLET in 1 BOTTLE (63629-3209-0) 40 tablet2021-12-080000-00-00NoNoCurrent
63629-3209-16362932090130 TABLET in 1 BOTTLE (63629-3209-1) 30 tablet2007-08-240000-00-00NoNoCurrent
63629-3209-26362932090260 TABLET in 1 BOTTLE (63629-3209-2) 60 tablet2007-04-250000-00-00NoNoCurrent
63629-3209-36362932090390 TABLET in 1 BOTTLE (63629-3209-3) 90 tablet2007-03-060000-00-00NoNoCurrent
63629-3209-463629320904120 TABLET in 1 BOTTLE (63629-3209-4) 120 tablet2008-09-170000-00-00NoNoCurrent
63629-3209-563629320905100 TABLET in 1 BOTTLE (63629-3209-5) 100 tablet2008-10-130000-00-00NoNoCurrent
63629-3209-66362932090684 TABLET in 1 BOTTLE (63629-3209-6) 84 tablet2010-03-040000-00-00NoNoCurrent
63629-3209-76362932090728 TABLET in 1 BOTTLE (63629-3209-7) 28 tablet2010-03-040000-00-00NoNoCurrent
63629-3209-86362932090821 TABLET in 1 BOTTLE (63629-3209-8) 21 tablet2010-11-170000-00-00NoNoCurrent
63629-3209-963629320909160 TABLET in 1 BOTTLE (63629-3209-9) 160 tablet2011-08-010000-00-00NoNoCurrent