tizanidine

Product NDC
71610-355
11-digit product format
716100355
Labeler code
71610
Product ID
71610-355_9daf813b-8fd4-4f12-96a5-d57049869e5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076533
Marketing category
ANDA
Marketing start
2004-01-16
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
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-355-16716100355166000 TABLET in 1 BOTTLE (71610-355-16) 6000 tablet2020-08-240000-00-00NoNoCurrent
71610-355-307161003553030 TABLET in 1 BOTTLE (71610-355-30) 30 tablet2019-11-180000-00-00NoNoCurrent
71610-355-537161003555360 TABLET in 1 BOTTLE (71610-355-53) 60 tablet2019-10-250000-00-00NoNoCurrent
71610-355-607161003556090 TABLET in 1 BOTTLE (71610-355-60) 90 tablet2019-10-250000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
tizanidineAphena Pharma Solutions - Tennessee, LLC2020-09-02HUMAN PRESCRIPTION DRUG LABEL2