FDA.reportPublic FDA data

tizanidine

Product NDC
71610-355
11-digit product format
716100355
Labeler code
71610
Product ID
71610-355_9daf813b-8fd4-4f12-96a5-d57049869e5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076533
Marketing category
ANDA
Marketing start
2004-01-16
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
2021-12-31
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
71610-355-162023-01-30C16284748780-1f386c649-d8b4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
71610-355-302023-01-30C16284748780-1f386c649-d8b4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
71610-355-532023-01-30C16284748780-1f386c649-d8b4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
71610-355-602023-01-30C16284748780-1f386c649-d8b4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-355-16tizanidine6000 in 1 BOTTLETABLET60002
71610-355-30tizanidine30 in 1 BOTTLETABLET302
71610-355-53tizanidine60 in 1 BOTTLETABLET602
71610-355-60tizanidine90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-355-30EA - Each71610-3559372f06f-b73a-4e38-b223-d381fbfdfbdb12020-03-10
71610-355-53EA - Each71610-3557e625ada-9e1f-4365-bbc6-7786edf714cc12019-12-10
71610-355-60EA - Each71610-3556d38c18b-1b23-4c67-9f0c-291a729e1ff612019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-355TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 4 package rows20200903_87ea1003-107e-4bc1-abd4-34977664c407.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN87ea1003-107e-4bc1-abd4-34977664c4072
313413tizanidine 4 MG Oral TabletSCD87ea1003-107e-4bc1-abd4-34977664c4072
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY87ea1003-107e-4bc1-abd4-34977664c4072

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-355-16716100355166000 TABLET in 1 BOTTLE (71610-355-16) 6000 tablet2020-08-240000-00-00NoNoCurrent
71610-355-307161003553030 TABLET in 1 BOTTLE (71610-355-30) 30 tablet2019-11-180000-00-00NoNoCurrent
71610-355-537161003555360 TABLET in 1 BOTTLE (71610-355-53) 60 tablet2019-10-250000-00-00NoNoCurrent
71610-355-607161003556090 TABLET in 1 BOTTLE (71610-355-60) 90 tablet2019-10-250000-00-00NoNoCurrent