Tizanidine

Product NDC
50090-2078
11-digit product format
500902078
Labeler code
50090
Product ID
50090-2078_2d65e205-9519-4d3a-a010-38c83fd6d6b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-2078-05009020780030 TABLET in 1 BOTTLE (50090-2078-0) 30 tablet2015-10-08NoNoHistorical
50090-2078-15009020780160 TABLET in 1 BOTTLE (50090-2078-1) 60 tablet2015-10-08NoNoHistorical
50090-2078-25009020780290 TABLET in 1 BOTTLE (50090-2078-2) 90 tablet2015-10-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TizanidineA-S Medication Solutions2025-04-02HUMAN PRESCRIPTION DRUG LABEL18