FDA.reportPublic FDA data

Tizanidine

Product NDC
63874-087
11-digit product format
638740087
Labeler code
63874
Product ID
63874-087_12c7793d-11c5-4f1b-883b-04e7aed3fb5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Altura Pharmaceuticals, Inc.
Application
ANDA076286
Marketing category
ANDA
Marketing start
2010-01-01
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
63874-087-012019-10-21C16284748780-1956f9ecf-d05c-621f-e053-dbdaa90a74adTizanidine Tablets USP
63874-087-042019-10-21C16284748780-1956f9ecf-d05c-621f-e053-dbdaa90a74adTizanidine Tablets USP
63874-087-302019-10-21C16284748780-1956f9ecf-d05c-621f-e053-dbdaa90a74adTizanidine Tablets USP
63874-087-602019-10-21C16284748780-1956f9ecf-d05c-621f-e053-dbdaa90a74adTizanidine Tablets USP
63874-087-902019-10-21C16284748780-1956f9ecf-d05c-621f-e053-dbdaa90a74adTizanidine Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63874-087-01Tizanidine100 in 1 BOTTLE, PLASTICTABLET1001
63874-087-04Tizanidine120 in 1 BOTTLE, PLASTICTABLET1201
63874-087-30Tizanidine30 in 1 BOTTLE, PLASTICTABLET301
63874-087-60Tizanidine60 in 1 BOTTLE, PLASTICTABLET601
63874-087-90Tizanidine90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63874-087-01EA - Each63874-087fbbb7c3a-8a38-4880-9f45-f333fe11997312012-07-24
63874-087-04EA - Each63874-0873ee269d5-64cb-4e29-83d6-1f2fb191fc4612012-07-24
63874-087-30EA - Each63874-087cac8eb7e-fda9-44f2-a638-03d2dcb91ebe12012-07-24
63874-087-60EA - Each63874-08734b30d0b-7f05-4384-87e3-8c50bc368e3512012-07-24
63874-087-90EA - Each63874-087aa696f74-4b76-4657-a034-1f7abbe0468d12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63874-087TIZANIDINE TABLET [ALTURA PHARMACEUTICALS, INC.]1Legacy NDC, 5 package rows20100430_9c70817f-e721-4f04-b095-0747702df614.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN9c70817f-e721-4f04-b095-0747702df6141
313412tizanidine 2 MG Oral TabletSCD9c70817f-e721-4f04-b095-0747702df6141
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY9c70817f-e721-4f04-b095-0747702df6141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63874-087-0163874008701100 in 1 BOTTLE, PLASTICHistorical
63874-087-0463874008704120 in 1 BOTTLE, PLASTICHistorical
63874-087-306387400873030 in 1 BOTTLE, PLASTICHistorical
63874-087-606387400876060 in 1 BOTTLE, PLASTICHistorical
63874-087-906387400879090 in 1 BOTTLE, PLASTICHistorical