FDA.reportPublic FDA data

TIZANIDINE

Product NDC
61919-220
11-digit product format
619190220
Labeler code
61919
Product ID
61919-220_e5424d7e-0818-49ec-a829-b79e1bd5262d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIZANIDINE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA076533
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
61919-220-722020-01-31C16284748780-19d75b9d0-7aad-f424-e053-dadaa90a57ceTIZANIDINE
61919-220-902020-01-31C16284748780-19d75b9d0-7aad-f424-e053-dadaa90a57ceTIZANIDINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-220-30TIZANIDINE30 in 1 BOTTLETABLET302
61919-220-60TIZANIDINE60 in 1 BOTTLETABLET602
61919-220-72TIZANIDINE120 in 1 BOTTLETABLET1202
61919-220-90TIZANIDINE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-220-30EA - Each61919-220c2d2814b-ae2b-4d91-afd0-13a386d35a9612014-06-03
61919-220-60EA - Each61919-220ac007417-d827-4fec-bc6a-495752ab250912015-10-02
61919-220-72EA - Each61919-220a4921e6d-b413-47b7-816f-7b1c486b98e812015-11-12
61919-220-90EA - Each61919-220ff509075-5951-407c-9ece-045ce2b81b2512014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [DIRECT RX]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [DIRECT RX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [DIRECT RX]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [DIRECT RX]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-220TIZANIDINE TABLET [DIRECT RX]2Legacy NDC, 4 package rows20151106_54bd58ee-76f6-44e7-83bb-fe752c3cbf9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tiZANidine HCl 4 MG Oral TabletPSN54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313412tizanidine 2 MG Oral TabletSCD54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tizanidine 4 MG Oral TabletSCD54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-220-306191902203030 in 1 BOTTLEHistorical
61919-220-606191902206060 in 1 BOTTLEHistorical
61919-220-7261919022072120 in 1 BOTTLEHistorical
61919-220-906191902209090 in 1 BOTTLEHistorical