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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
B53E3NMY5CTIZANIDINE HYDROCHLORIDE64461-82-1TIZANIDINE HYDROCHLORIDE
6AI06C00GWTIZANIDINE51322-75-9Tizanidine

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-3209-06362932090040 TABLET in 1 BOTTLE (63629-3209-0) 40 tablet2021-12-08NoNoHistorical
63629-3209-16362932090130 TABLET in 1 BOTTLE (63629-3209-1) 30 tablet2007-08-24NoNoHistorical
63629-3209-26362932090260 TABLET in 1 BOTTLE (63629-3209-2) 60 tablet2007-04-25NoNoHistorical
63629-3209-36362932090390 TABLET in 1 BOTTLE (63629-3209-3) 90 tablet2007-03-06NoNoHistorical
63629-3209-463629320904120 TABLET in 1 BOTTLE (63629-3209-4) 120 tablet2008-09-17NoNoHistorical
63629-3209-563629320905100 TABLET in 1 BOTTLE (63629-3209-5) 100 tablet2008-10-13NoNoHistorical
63629-3209-66362932090684 TABLET in 1 BOTTLE (63629-3209-6) 84 tablet2010-03-04NoNoHistorical
63629-3209-76362932090728 TABLET in 1 BOTTLE (63629-3209-7) 28 tablet2010-03-04NoNoHistorical
63629-3209-86362932090821 TABLET in 1 BOTTLE (63629-3209-8) 21 tablet2010-11-17NoNoHistorical
63629-3209-963629320909160 TABLET in 1 BOTTLE (63629-3209-9) 160 tablet2011-08-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TizanidineBryant Ranch Prepack2021-12-08HUMAN PRESCRIPTION DRUG LABEL4