TIZANIDINE HYDROCHLORIDE

Product NDC
60760-892
11-digit product format
607600892
Labeler code
60760
Product ID
60760-892_4009c0a9-d2e0-3595-e063-6294a90aa2a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA210267
Marketing category
ANDA
Marketing start
2019-03-20
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
6 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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-892-306076008923030 CAPSULE in 1 BOTTLE, PLASTIC (60760-892-30) 30 capsule2025-09-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TIZANIDINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY2025-09-30HUMAN PRESCRIPTION DRUG LABEL1