Tizanidine

Product NDC
52959-689
11-digit product format
529590689
Labeler code
52959
Product ID
52959-689_efa8102d-2da1-4d92-b884-fd9c8bd80383
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA076286
Marketing category
ANDA
Marketing start
2002-07-03
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
E
Listing certified through
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-689-02Tizanidine120 in 1 BOTTLETABLET1203
52959-689-05Tizanidine150 in 1 BOTTLETABLET1503
52959-689-08Tizanidine180 in 1 BOTTLETABLET1803
52959-689-15Tizanidine15 in 1 BOTTLETABLET153
52959-689-20Tizanidine20 in 1 BOTTLETABLET203
52959-689-21Tizanidine21 in 1 BOTTLETABLET213
52959-689-30Tizanidine30 in 1 BOTTLETABLET303
52959-689-42Tizanidine42 in 1 BOTTLETABLET423
52959-689-45Tizanidine45 in 1 BOTTLETABLET453
52959-689-60Tizanidine60 in 1 BOTTLETABLET603
52959-689-63Tizanidine63 in 1 BOTTLETABLET633
52959-689-90Tizanidine90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-689-02EA - Each52959-689d929b0ec-e09d-4cdb-8efa-e91960d0cd5b12012-07-24
52959-689-05EA - Each52959-6891b9fb586-9d86-4948-b388-3472dfc9965612012-07-24
52959-689-08EA - Each52959-689c7f4608a-12eb-40a1-8008-e62a30bb88b312012-07-24
52959-689-15EA - Each52959-689f1b352a4-69e9-4a7d-bb34-12221e0af13012012-07-24
52959-689-20EA - Each52959-689b48ca786-40da-4149-9119-fef921d0586212012-07-24
52959-689-21EA - Each52959-68912cab2ba-ea28-412e-9a48-b53c4536a49912012-07-24
52959-689-30EA - Each52959-68981d75dfd-e141-4dd7-850e-72bd1e83b72c12012-07-24
52959-689-42EA - Each52959-6891919fb4a-d8e4-4277-a27e-cd0603044e8612012-07-24
52959-689-45EA - Each52959-689f7df5488-90b1-45ce-8007-cd1817d9ec4a12012-07-24
52959-689-60EA - Each52959-689df80fa83-f853-4503-96d1-ef30e3466f4e12012-07-24
52959-689-63EA - Each52959-68915b32e41-f27c-4469-8fd0-5b24dae7f76a12012-07-24
52959-689-90EA - Each52959-689fcbafa4e-d1d6-4d6e-aceb-9cd4e3929a6f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [H.J. HARKINS COMPANY, INC.]3
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-689TIZANIDINE TABLET [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 12 package rows20111222_6d8e0262-5ccf-4447-90dd-f5eec069664c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN6d8e0262-5ccf-4447-90dd-f5eec069664c3
313413tiZANidine HCl 4 MG Oral TabletPSN6d8e0262-5ccf-4447-90dd-f5eec069664c3
313412tizanidine 2 MG Oral TabletSCD6d8e0262-5ccf-4447-90dd-f5eec069664c3
313413tizanidine 4 MG Oral TabletSCD6d8e0262-5ccf-4447-90dd-f5eec069664c3
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY6d8e0262-5ccf-4447-90dd-f5eec069664c3
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY6d8e0262-5ccf-4447-90dd-f5eec069664c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-689-0252959068902120 in 1 BOTTLEHistorical
52959-689-0552959068905150 in 1 BOTTLEHistorical
52959-689-0852959068908180 in 1 BOTTLEHistorical
52959-689-155295906891515 in 1 BOTTLEHistorical
52959-689-205295906892020 in 1 BOTTLEHistorical
52959-689-215295906892121 in 1 BOTTLEHistorical
52959-689-305295906893030 in 1 BOTTLEHistorical
52959-689-425295906894242 in 1 BOTTLEHistorical
52959-689-455295906894545 in 1 BOTTLEHistorical
52959-689-605295906896060 in 1 BOTTLEHistorical
52959-689-635295906896363 in 1 BOTTLEHistorical
52959-689-905295906899090 in 1 BOTTLEHistorical