Tizanidine

Product NDC
68071-3440
11-digit product format
680713440
Labeler code
68071
Product ID
68071-3440_2d588782-a006-adf6-e063-6294a90ada33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
68071-3440-96807134400990 TABLET in 1 BOTTLE (68071-3440-9) 90 tablet2023-06-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TizanidineNuCare Pharmaceuticals,Inc.2025-02-04HUMAN PRESCRIPTION DRUG LABEL2