Tizanidine

Product NDC
66336-843
11-digit product format
663360843
Labeler code
66336
Product ID
66336-843_9cf56195-c94a-4fb0-8ce7-813c55a0502f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
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
E
Listing certified through
2017-12-31
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
66336-843-602019-11-27C16284748780-19855e2a2-3c60-60a7-e053-dbdaa90a05bdTizanidine Tablets USP
66336-843-622019-11-27C16284748780-19855e2a2-3c60-60a7-e053-dbdaa90a05bdTizanidine Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-843-60Tizanidine60 in 1 BOTTLETABLET601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [DISPENSING SOLUTIONS, INC.]1
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [DISPENSING SOLUTIONS, INC.]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [DISPENSING SOLUTIONS, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [DISPENSING SOLUTIONS, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [DISPENSING SOLUTIONS, INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-843TIZANIDINE TABLET [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20130710_0d2aaf19-74ae-4aff-a33a-1d1a54aa1b8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN0d2aaf19-74ae-4aff-a33a-1d1a54aa1b8c1
313413tizanidine 4 MG Oral TabletSCD0d2aaf19-74ae-4aff-a33a-1d1a54aa1b8c1
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY0d2aaf19-74ae-4aff-a33a-1d1a54aa1b8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-843-606633608436060 in 1 BOTTLEHistorical