FDA.reportPublic FDA data

Tizanidine

Product NDC
63629-1673
11-digit product format
636291673
Labeler code
63629
Product ID
63629-1673_b87823c8-5dc9-4558-b145-b4b4ff8a7d25
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
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
63629-1673-02021-12-29C16284748780-19d75b9d0-1108-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
63629-1673-12021-12-29C16284748780-19d75b9d0-1108-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
63629-1673-22021-12-29C16284748780-19d75b9d0-1108-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
63629-1673-32021-12-29C16284748780-19d75b9d0-1108-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
63629-1673-42021-12-29C16284748780-19d75b9d0-1108-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
63629-1673-52021-12-29C16284748780-19d75b9d0-1108-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
63629-1673-62021-12-29C16284748780-19d75b9d0-1108-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
63629-1673-72021-12-29C16284748780-19d75b9d0-1108-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
63629-1673-82021-12-29C16284748780-19d75b9d0-1108-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
63629-1673-92021-12-29C16284748780-19d75b9d0-1108-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
63629-1673-02020-01-31C16284748780-19d75b9d0-1108-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
63629-1673-12020-01-31C16284748780-19d75b9d0-1108-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
63629-1673-22020-01-31C16284748780-19d75b9d0-1108-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
63629-1673-32020-01-31C16284748780-19d75b9d0-1108-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
63629-1673-42020-01-31C16284748780-19d75b9d0-1108-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
63629-1673-52020-01-31C16284748780-19d75b9d0-1108-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
63629-1673-62020-01-31C16284748780-19d75b9d0-1108-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
63629-1673-72020-01-31C16284748780-19d75b9d0-1108-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
63629-1673-82020-01-31C16284748780-19d75b9d0-1108-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
63629-1673-92020-01-31C16284748780-19d75b9d0-1108-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
63629-1673-0Tizanidine112 in 1 BOTTLETABLET11218
63629-1673-1Tizanidine30 in 1 BOTTLETABLET3018
63629-1673-2Tizanidine60 in 1 BOTTLETABLET6018
63629-1673-3Tizanidine90 in 1 BOTTLETABLET9018
63629-1673-4Tizanidine120 in 1 BOTTLETABLET12018
63629-1673-5Tizanidine20 in 1 BOTTLETABLET2018
63629-1673-6Tizanidine45 in 1 BOTTLETABLET4518
63629-1673-7Tizanidine140 in 1 BOTTLETABLET14018
63629-1673-8Tizanidine84 in 1 BOTTLETABLET8418
63629-1673-9Tizanidine28 in 1 BOTTLETABLET2818

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1673-1EA - Each63629-1673523822ff-56d0-4603-bbde-653d7f88ad2212012-07-24
63629-1673-2EA - Each63629-1673345bcbff-c858-4c7d-9e45-824a8dd0b09912012-07-24
63629-1673-3EA - Each63629-167322b0fae4-e674-4541-99b3-4d424909a08412012-07-24
63629-1673-4EA - Each63629-1673aa8bc57a-d99a-4c5d-a95a-28c58bee64f112012-07-24
63629-1673-5EA - Each63629-1673ec4ba410-5e6e-43fb-ab82-727366f892e812012-07-24
63629-1673-6EA - Each63629-1673d1d640fb-5be2-4bd1-8459-fca8f36642ea12012-07-24
63629-1673-7EA - Each63629-167379ad9468-eda3-4ebf-a611-10556a9af0c412012-07-24
63629-1673-8EA - Each63629-167304b27aaa-74ba-441f-8c3a-d40e3aa5fdb012015-02-02
63629-1673-9EA - Each63629-1673748341b8-480b-4f3b-a37d-3b00db11588b12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [BRYANT RANCH PREPACK]2
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [BRYANT RANCH PREPACK]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [BRYANT RANCH PREPACK]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [BRYANT RANCH PREPACK]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [BRYANT RANCH PREPACK]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1673TIZANIDINE TABLET [BRYANT RANCH PREPACK]18Current NDC, Legacy NDC, 10 package rows20240820_b254a0f4-efb1-4874-ae45-1dc5fe316964.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNb254a0f4-efb1-4874-ae45-1dc5fe31696418
313413tizanidine 4 MG Oral TabletSCDb254a0f4-efb1-4874-ae45-1dc5fe31696418
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYb254a0f4-efb1-4874-ae45-1dc5fe31696418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1673-063629167300112 TABLET in 1 BOTTLE (63629-1673-0) 112 tablet2002-07-030000-00-00NoNoCurrent
63629-1673-16362916730130 TABLET in 1 BOTTLE (63629-1673-1) 30 tablet2002-07-030000-00-00NoNoCurrent
63629-1673-26362916730260 TABLET in 1 BOTTLE (63629-1673-2) 60 tablet2002-07-030000-00-00NoNoCurrent
63629-1673-36362916730390 TABLET in 1 BOTTLE (63629-1673-3) 90 tablet2002-07-030000-00-00NoNoCurrent
63629-1673-463629167304120 TABLET in 1 BOTTLE (63629-1673-4) 120 tablet2002-07-030000-00-00NoNoCurrent
63629-1673-56362916730520 TABLET in 1 BOTTLE (63629-1673-5) 20 tablet2002-07-030000-00-00NoNoCurrent
63629-1673-66362916730645 TABLET in 1 BOTTLE (63629-1673-6) 45 tablet2002-07-030000-00-00NoNoCurrent
63629-1673-763629167307140 TABLET in 1 BOTTLE (63629-1673-7) 140 tablet2002-07-030000-00-00NoNoCurrent
63629-1673-86362916730884 TABLET in 1 BOTTLE (63629-1673-8) 84 tablet2002-07-030000-00-00NoNoCurrent
63629-1673-96362916730928 TABLET in 1 BOTTLE (63629-1673-9) 28 tablet2002-07-030000-00-00NoNoCurrent