TIZANIDINE HYDROCHLORIDE

Product NDC
68387-130
11-digit product format
683870130
Labeler code
68387
Product ID
68387-130_8eba76b2-3510-40b2-a169-e8c1aea145e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIZANIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA076347
Marketing category
ANDA
Marketing start
2005-06-01
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
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68387-130-302019-10-21C16284748780-1956f9ecf-c1cb-621f-e053-dbdaa90a74adTizanidine hydrochloride Tablets
68387-130-902019-10-21C16284748780-1956f9ecf-c1cb-621f-e053-dbdaa90a74adTizanidine hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-130-30TIZANIDINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET303
68387-130-90TIZANIDINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-130-30EA - Each68387-13053048c14-ebae-4244-9c5d-b75b59eb89f312012-07-24
68387-130-90EA - Each68387-13064f9a218-50c0-489e-bd91-d5246e05329112012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-130TIZANIDINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]3Legacy NDC, 2 package rows20100713_0df212f5-f77b-4d94-8fd0-0b40d0e9a1c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83
313413tiZANidine HCl 4 MG Oral TabletPSN0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83
313412tizanidine 2 MG Oral TabletSCD0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83
313413tizanidine 4 MG Oral TabletSCD0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-130-306838701303030 in 1 BOTTLE, PLASTICHistorical
68387-130-906838701309090 in 1 BOTTLE, PLASTICHistorical