Tizanidine Hydrochloride

Product NDC
59746-672
11-digit product format
597460672
Labeler code
59746
Product ID
59746-672_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
6 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0ff02d8-b711-423c-b7d1-ada00d81c743Product name120250805
9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01Product name820250313
b404127e-1c01-47bb-874e-db1e0b6bd9afProduct name420250313

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-672-34EA - Each59746-672911c1ab4-abdc-4eb4-b566-5150baf3e5ca12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-672TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3Legacy NDC20170811_e803d28e-0610-a52c-3295-dd2d148531aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485484tiZANidine HCl 6 MG Oral CapsulePSN6f5ba3eb-3af5-4608-9bc1-2c5be25cd2322
485484tizanidine 6 MG Oral CapsuleSCD6f5ba3eb-3af5-4608-9bc1-2c5be25cd2322
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY6f5ba3eb-3af5-4608-9bc1-2c5be25cd2322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-672-0159746067201100 CAPSULE in 1 BOTTLE (59746-672-01) 100 capsule2017-08-040000-00-00NoNoCurrent
59746-672-0559746067205500 CAPSULE in 1 BOTTLE (59746-672-05) 500 capsule2017-08-040000-00-00NoNoCurrent
59746-672-305974606723030 CAPSULE in 1 BOTTLE (59746-672-30) 30 capsule2017-08-040000-00-00NoNoCurrent
59746-672-3459746067234150 CAPSULE in 1 BOTTLE (59746-672-34) 150 capsule2017-08-040000-00-00NoNoCurrent