FDA.reportPublic FDA data

TIZANIDINE HYDROCHLORIDE

Product NDC
61919-196
11-digit product format
619190196
Labeler code
61919
Product ID
61919-196_4c484458-33e2-e0cc-e063-6294a90a9e28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIZANIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
TIZANIDINE HYDROCHLORIDE
Application
ANDA091283
Marketing category
ANDA
Marketing start
2014-01-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TIZANIDINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313413

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
61919-196-302025-01-30C16284748780-12cef2736-8331-d83d-e063-dadaa90ab31fTIZANIDINE HYDROCHLORIDE
61919-196-402025-01-30C16284748780-12cef2736-8331-d83d-e063-dadaa90ab31fTIZANIDINE HYDROCHLORIDE
61919-196-602025-01-30C16284748780-12cef2736-8331-d83d-e063-dadaa90ab31fTIZANIDINE HYDROCHLORIDE
61919-196-722025-01-30C16284748780-12cef2736-8331-d83d-e063-dadaa90ab31fTIZANIDINE HYDROCHLORIDE
61919-196-902025-01-30C16284748780-12cef2736-8331-d83d-e063-dadaa90ab31fTIZANIDINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-196-20TIZANIDINE HYDROCHLORIDE20 in 1 BOTTLETABLET207
61919-196-30TIZANIDINE HYDROCHLORIDE30 in 1 BOTTLETABLET307
61919-196-40TIZANIDINE HYDROCHLORIDE40 in 1 BOTTLETABLET407
61919-196-60TIZANIDINE HYDROCHLORIDE60 in 1 BOTTLETABLET607
61919-196-72TIZANIDINE HYDROCHLORIDE72 in 1 BOTTLETABLET727
61919-196-90TIZANIDINE HYDROCHLORIDE90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-196-30EA - Each61919-196d9738507-dea3-4be7-b22f-54f870b4281512015-04-03
61919-196-40EA - Each61919-196531d7162-f55a-4f54-97fb-dc6d3a53d61712021-07-15
61919-196-60EA - Each61919-1963c5664c8-e3b7-49a1-b452-6250761e780c12015-04-03
61919-196-72EA - Each61919-196398afc75-eec5-4737-90e2-35b0d20222cb12015-04-03
61919-196-90EA - Each61919-1963e8bbb6b-c8c9-4c8b-81ef-dd2fc12dc44212015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-196TIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]6Current NDC, Legacy NDC, 6 package rows20230413_047c67cd-7a63-49c9-b100-71651d3537ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN047c67cd-7a63-49c9-b100-71651d3537ba7
313413tizanidine 4 MG Oral TabletSCD047c67cd-7a63-49c9-b100-71651d3537ba7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY047c67cd-7a63-49c9-b100-71651d3537ba7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-196-206191901962020 TABLET in 1 BOTTLE (61919-196-20) 20 tablet2014-01-01NoNoHistorical
61919-196-306191901963030 TABLET in 1 BOTTLE (61919-196-30) 30 tablet2015-01-010000-00-00NoNoCurrent
61919-196-406191901964040 TABLET in 1 BOTTLE (61919-196-40) 40 tablet2014-01-010000-00-00NoNoCurrent
61919-196-606191901966060 TABLET in 1 BOTTLE (61919-196-60) 60 tablet2015-01-010000-00-00NoNoCurrent
61919-196-726191901967272 TABLET in 1 BOTTLE (61919-196-72) 72 tablet2015-01-010000-00-00NoNoCurrent
61919-196-906191901969090 TABLET in 1 BOTTLE (61919-196-90) 90 tablet2015-01-010000-00-00NoNoCurrent