Tizanidine

Product NDC
45865-348
11-digit product format
458650348
Labeler code
45865
Product ID
45865-348_db154152-f820-455d-a524-34591ca94e87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA076286
Marketing category
ANDA
Marketing start
2008-12-08
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-348-30Tizanidine30 in 1 BOTTLETABLET302
45865-348-51Tizanidine120 in 1 BOTTLETABLET1202
45865-348-60Tizanidine60 in 1 BOTTLETABLET602
45865-348-84Tizanidine84 in 1 BOTTLETABLET842
45865-348-90Tizanidine90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-348TIZANIDINE TABLET [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 5 package rows20120818_c14fa366-721d-47d1-928a-ae2fb250752d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNc14fa366-721d-47d1-928a-ae2fb250752d2
313413tizanidine 4 MG Oral TabletSCDc14fa366-721d-47d1-928a-ae2fb250752d2
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYc14fa366-721d-47d1-928a-ae2fb250752d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-348-304586503483030 in 1 BOTTLEHistorical
45865-348-5145865034851120 in 1 BOTTLEHistorical
45865-348-604586503486060 in 1 BOTTLEHistorical
45865-348-844586503488484 in 1 BOTTLEHistorical
45865-348-904586503489090 in 1 BOTTLEHistorical