tizanidine

Product NDC
50090-7716
11-digit product format
500907716
Labeler code
50090
Product ID
50090-7716_9edb8ad4-7e86-4eb9-b5b9-466b466c3fe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA218920
Marketing category
ANDA
Marketing start
2024-12-15
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
50090-7716-05009077160030 TABLET in 1 BOTTLE (50090-7716-0) 30 tablet2025-10-15NoNoHistorical
50090-7716-15009077160160 TABLET in 1 BOTTLE (50090-7716-1) 60 tablet2025-10-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
tizanidineA-S Medication Solutions2025-10-17HUMAN PRESCRIPTION DRUG LABEL1