FDA.reportPublic FDA data

Tizanidine Hydrochloride

Product NDC
45865-954
11-digit product format
458650954
Labeler code
45865
Product ID
45865-954_9addc6af-dffb-0942-e053-2a95a90ac997
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine Hydrochloride
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA078868
Marketing category
ANDA
Marketing start
2012-02-06
Marketing end
0000-00-00
Substance
TIZANIDINE HYDROCHLORIDE
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-954-302025-01-30C16284748780-12cef2736-ade5-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES . TIZANIDINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-954-30Tizanidine Hydrochloride30 in 1 BOTTLECAPSULE, GELATIN COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-954TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191230_9addc6af-dffa-0942-e053-2a95a90ac997.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485484tiZANidine HCl 6 MG Oral CapsulePSN9addc6af-dffa-0942-e053-2a95a90ac9971
485484tizanidine 6 MG Oral CapsuleSCD9addc6af-dffa-0942-e053-2a95a90ac9971
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY9addc6af-dffa-0942-e053-2a95a90ac9971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-954-304586509543030 CAPSULE, GELATIN COATED in 1 BOTTLE (45865-954-30) 2018-12-120000-00-00NoNoCurrent