FDA.reportPublic FDA data

tizanidine

Product NDC
10544-863
11-digit product format
105440863
Labeler code
10544
Product ID
10544-863_1fe204a5-8ca9-1fa1-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
2014-04-08
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
10544-863-022020-01-31C16284748780-19d75b9d0-4d98-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
10544-863-302020-01-31C16284748780-19d75b9d0-4d98-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
10544-863-602020-01-31C16284748780-19d75b9d0-4d98-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
10544-863-842020-01-31C16284748780-19d75b9d0-4d98-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
10544-863-902020-01-31C16284748780-19d75b9d0-4d98-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
10544-863-02tizanidine120 in 1 BOTTLETABLET1201
10544-863-30tizanidine30 in 1 BOTTLETABLET301
10544-863-60tizanidine60 in 1 BOTTLETABLET601
10544-863-84tizanidine84 in 1 BOTTLETABLET841
10544-863-90tizanidine90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-863-02EA - Each10544-86373e4cd21-75da-4b8f-851e-8d63ad14d45a12015-10-02
10544-863-30EA - Each10544-863375a9571-ce1d-4639-82ab-a0ac1dadf1f212015-10-02
10544-863-60EA - Each10544-86310f5b0aa-9969-41bc-b0cf-4e09ff2abec712015-10-02
10544-863-84EA - Each10544-863ae297845-8b65-4bba-923b-877c9371ee3312015-10-02
10544-863-90EA - Each10544-863324269f8-1acd-4ee3-94c3-c3c9d684bca212015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-863TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 5 package rows20150916_1fe204a5-8ca8-1fa1-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN1fe204a5-8ca8-1fa1-e054-00144ff8d46c1
313412tizanidine 2 MG Oral TabletSCD1fe204a5-8ca8-1fa1-e054-00144ff8d46c1
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY1fe204a5-8ca8-1fa1-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-863-0210544086302120 in 1 BOTTLEHistorical
10544-863-301054408633030 in 1 BOTTLEHistorical
10544-863-601054408636060 in 1 BOTTLEHistorical
10544-863-841054408638484 in 1 BOTTLEHistorical
10544-863-901054408639090 in 1 BOTTLEHistorical