FDA.reportPublic FDA data

tizanidine

Product NDC
10544-587
11-digit product format
105440587
Labeler code
10544
Product ID
10544-587_1466fd7c-7f9c-548b-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA076533
Marketing category
ANDA
Marketing start
2014-01-13
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
10544-587-302020-01-31C16284748780-19d75b9d0-c90d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996
10544-587-602020-01-31C16284748780-19d75b9d0-c90d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996
10544-587-902020-01-31C16284748780-19d75b9d0-c90d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-587-30tizanidine30 in 1 BOTTLETABLET304
10544-587-60tizanidine60 in 1 BOTTLETABLET604
10544-587-90tizanidine90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-587-60EA - Each10544-5879865fb1a-894d-46a6-92f3-54fbbf569a7d12015-10-02
10544-587-90EA - Each10544-587b1446f66-472b-435f-be27-170143b41d9e12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-587TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4Legacy NDC, 3 package rows20150423_10457e1d-068f-7071-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN10457e1d-068f-7071-e054-00144ff8d46c4
313412tizanidine 2 MG Oral TabletSCD10457e1d-068f-7071-e054-00144ff8d46c4
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY10457e1d-068f-7071-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-587-301054405873030 in 1 BOTTLEHistorical
10544-587-601054405876060 in 1 BOTTLEHistorical
10544-587-901054405879090 in 1 BOTTLEHistorical