FDA.reportPublic FDA data

Tizanidine

Product NDC
50436-6755
11-digit product format
504366755
Labeler code
50436
Product ID
50436-6755_5ec52e0b-9ae4-41d0-9dda-fc2a28b8898e
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
2 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
50436-6755-12020-01-31C16284748780-19d75b9d0-9b8f-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
50436-6755-22020-01-31C16284748780-19d75b9d0-9b8f-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
50436-6755-32020-01-31C16284748780-19d75b9d0-9b8f-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
50436-6755-1Tizanidine30 in 1 BOTTLETABLET307
50436-6755-2Tizanidine60 in 1 BOTTLETABLET607
50436-6755-3Tizanidine90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6755-1EA - Each50436-67553243d827-8e4f-4dc9-81aa-d66eba4f26aa12012-07-24
50436-6755-2EA - Each50436-6755e1629c3c-c428-46b3-99ed-4ec99c5a291712012-07-24
50436-6755-3EA - Each50436-6755fe0d3807-8fcf-48e7-b7d2-3cc33fdc15f812012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6755TIZANIDINE TABLET [UNIT DOSE SERVICES]7Legacy NDC, 3 package rows20171207_988cbeae-64ed-4ce1-b503-f5e7b77f1a2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN988cbeae-64ed-4ce1-b503-f5e7b77f1a2a7
313412tizanidine 2 MG Oral TabletSCD988cbeae-64ed-4ce1-b503-f5e7b77f1a2a7
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY988cbeae-64ed-4ce1-b503-f5e7b77f1a2a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6755-15043667550130 in 1 BOTTLEHistorical
50436-6755-25043667550260 in 1 BOTTLEHistorical
50436-6755-35043667550390 in 1 BOTTLEHistorical