Tizanidine

Product NDC
63187-910
11-digit product format
631870910
Labeler code
63187
Product ID
63187-910_fdcb382b-4753-45e8-ab3c-28d929c764b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091283
Marketing category
ANDA
Marketing start
2013-04-01
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
63187-910-306318709103030 TABLET in 1 BOTTLE, PLASTIC (63187-910-30) 30 tablet2017-09-01NoNoHistorical
63187-910-606318709106060 TABLET in 1 BOTTLE, PLASTIC (63187-910-60) 60 tablet2017-09-01NoNoHistorical
63187-910-906318709109090 TABLET in 1 BOTTLE, PLASTIC (63187-910-90) 90 tablet2017-09-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TizanidineProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL5