Tizanidine Hydrochloride

Product NDC
59746-670
11-digit product format
597460670
Labeler code
59746
Product ID
59746-670_b384b1a9-6301-4d3f-a6f1-4deb5f58e6e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA209605
Marketing category
ANDA
Marketing start
2017-08-04
Marketing end
0000-00-00
Substance
TIZANIDINE
Active strength
2 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-670-34EA - Each59746-6709649a135-e5ca-44bf-99b8-abf8891f4ab212018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-670TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3Legacy NDC20170811_e803d28e-0610-a52c-3295-dd2d148531aa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-670-0159746067001100 CAPSULE in 1 BOTTLE (59746-670-01) 100 capsule2017-08-040000-00-00NoNoCurrent
59746-670-10597460670101000 CAPSULE in 1 BOTTLE (59746-670-10) 1000 capsule2017-08-040000-00-00NoNoCurrent
59746-670-305974606703030 CAPSULE in 1 BOTTLE (59746-670-30) 30 capsule2017-08-040000-00-00NoNoCurrent
59746-670-3459746067034150 CAPSULE in 1 BOTTLE (59746-670-34) 150 capsule2017-08-040000-00-00NoNoCurrent