FDA.reportPublic FDA data

Tizanidine Hydrochloride

Product NDC
71335-1698
11-digit product format
713351698
Labeler code
71335
Product ID
71335-1698_d6cf6571-ae8c-4084-8ae9-8ee613b68f7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209605
Marketing category
ANDA
Marketing start
2017-08-04
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
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
71335-1698-12024-01-30C16284748780-11030e365-4ed4-111a-e063-dadaa90a10e2These 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
71335-1698-22024-01-30C16284748780-11030e365-4ed4-111a-e063-dadaa90a10e2These 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
71335-1698-32024-01-30C16284748780-11030e365-4ed4-111a-e063-dadaa90a10e2These 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
71335-1698-42024-01-30C16284748780-11030e365-4ed4-111a-e063-dadaa90a10e2These 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
71335-1698-52024-01-30C16284748780-11030e365-4ed4-111a-e063-dadaa90a10e2These 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
71335-1698-1Tizanidine Hydrochloride30 in 1 BOTTLECAPSULE302
71335-1698-2Tizanidine Hydrochloride60 in 1 BOTTLECAPSULE602
71335-1698-3Tizanidine Hydrochloride90 in 1 BOTTLECAPSULE902
71335-1698-4Tizanidine Hydrochloride120 in 1 BOTTLECAPSULE1202
71335-1698-5Tizanidine Hydrochloride28 in 1 BOTTLECAPSULE282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1698TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]2Legacy NDC, 5 package rows20221206_6f5ba3eb-3af5-4608-9bc1-2c5be25cd232.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
71335-1698-17133516980130 CAPSULE in 1 BOTTLE (71335-1698-1) 30 capsule2020-09-010000-00-00NoNoCurrent
71335-1698-27133516980260 CAPSULE in 1 BOTTLE (71335-1698-2) 60 capsule2020-09-010000-00-00NoNoCurrent
71335-1698-37133516980390 CAPSULE in 1 BOTTLE (71335-1698-3) 90 capsule2020-09-010000-00-00NoNoCurrent
71335-1698-471335169804120 CAPSULE in 1 BOTTLE (71335-1698-4) 120 capsule2020-09-010000-00-00NoNoCurrent
71335-1698-57133516980528 CAPSULE in 1 BOTTLE (71335-1698-5) 28 capsule2020-09-010000-00-00NoNoCurrent