FDA.reportPublic FDA data

TIZANIDINE

Product NDC
61919-221
11-digit product format
619190221
Labeler code
61919
Product ID
61919-221_eac3d220-1419-7750-e053-2a95a90a6f04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIZANIDINE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA076533
Marketing category
ANDA
Marketing start
2019-09-30
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
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
61919-221-722020-01-31C16284748780-19d75b9d0-7aad-f424-e053-dadaa90a57ceTIZANIDINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-221-30TIZANIDINE30 in 1 BOTTLETABLET302
61919-221-60TIZANIDINE60 in 1 BOTTLETABLET602
61919-221-72TIZANIDINE120 in 1 BOTTLETABLET1202
61919-221-90TIZANIDINE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-221-15EA - Each61919-221215117cd-08bd-4a81-adc0-138a7beb7df112019-10-07
61919-221-30EA - Each61919-2212f58fb4b-1857-4b5d-b1a2-21b1f5adfca412014-07-02
61919-221-60EA - Each61919-2215dfe56f5-ffbc-4a49-a4e1-0df0d9c16dd612014-10-03
61919-221-72EA - Each61919-221f104c843-417f-4436-9227-e72cfdfefc6312014-07-02
61919-221-86EA - Each61919-2210fbd2fee-4a39-458c-a7ac-9926c6f60a1d12019-09-05
61919-221-90EA - Each61919-2218080cee6-a39a-4bc1-9868-cb20d50852f712014-07-02

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
61919-221TIZANIDINE 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-221-156191902211515 TABLET in 1 BOTTLE (61919-221-15) 15 tablet2019-09-300000-00-00NoNoCurrent
61919-221-306191902213030 in 1 BOTTLEHistorical
61919-221-606191902216060 in 1 BOTTLEHistorical
61919-221-7261919022172120 in 1 BOTTLEHistorical
61919-221-8661919022186270 TABLET in 1 BOTTLE (61919-221-86) 270 tablet2019-08-130000-00-00NoNoCurrent
61919-221-906191902219090 in 1 BOTTLEHistorical