tizanidine

Product NDC
68788-9497
11-digit product format
687889497
Labeler code
68788
Product ID
68788-9497_f1b95df7-03f0-4b8b-83b6-912d0875203f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA076533
Marketing category
ANDA
Marketing start
2014-03-26
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9497-26878894970228 TABLET in 1 BOTTLE (68788-9497-2) 28 tablet2016-09-200000-00-00NoNoCurrent
68788-9497-36878894970330 TABLET in 1 BOTTLE (68788-9497-3) 30 tablet2014-03-260000-00-00NoNoCurrent
68788-9497-66878894970660 TABLET in 1 BOTTLE (68788-9497-6) 60 tablet2014-03-260000-00-00NoNoCurrent
68788-9497-868788949708120 TABLET in 1 BOTTLE (68788-9497-8) 120 tablet2014-03-260000-00-00NoNoCurrent
68788-9497-96878894970990 TABLET in 1 BOTTLE (68788-9497-9) 90 tablet2014-03-260000-00-00NoNoCurrent