tizanidine

Product NDC
67296-1599
11-digit product format
672961599
Labeler code
67296
Product ID
67296-1599_d61c2edd-020c-04be-e053-2a95a90ac50e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076533
Marketing category
ANDA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
67296-1599-12024-08-15C16284748780-11030e365-46b6-111a-e063-dadaa90a10e2tizanidine
67296-1599-12024-01-30C16284748780-11030e365-46b6-111a-e063-dadaa90a10e2tizanidine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1599-1tizanidine15 in 1 BOTTLETABLET154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1599TIZANIDINE TABLET [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20240816_6a9c62c6-56ce-775e-e053-2991aa0ac922.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN6a9c62c6-56ce-775e-e053-2991aa0ac9224
313413tizanidine 4 MG Oral TabletSCD6a9c62c6-56ce-775e-e053-2991aa0ac9224
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY6a9c62c6-56ce-775e-e053-2991aa0ac9224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1599-16729615990115 TABLET in 1 BOTTLE (67296-1599-1) 15 tablet2018-01-010000-00-00NoNoCurrent