FDA.reportPublic FDA data

Tizanidine

Product NDC
52959-691
11-digit product format
529590691
Labeler code
52959
Product ID
52959-691_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
2 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-691-002020-01-31C16284748780-19d75b9d1-0cf6-f424-e053-dadaa90a57ceTizanidine Tablets USP
52959-691-022020-01-31C16284748780-19d75b9d1-0cf6-f424-e053-dadaa90a57ceTizanidine Tablets USP
52959-691-052020-01-31C16284748780-19d75b9d1-0cf6-f424-e053-dadaa90a57ceTizanidine Tablets USP
52959-691-202020-01-31C16284748780-19d75b9d1-0cf6-f424-e053-dadaa90a57ceTizanidine Tablets USP
52959-691-242020-01-31C16284748780-19d75b9d1-0cf6-f424-e053-dadaa90a57ceTizanidine Tablets USP
52959-691-252020-01-31C16284748780-19d75b9d1-0cf6-f424-e053-dadaa90a57ceTizanidine Tablets USP
52959-691-302020-01-31C16284748780-19d75b9d1-0cf6-f424-e053-dadaa90a57ceTizanidine Tablets USP
52959-691-452020-01-31C16284748780-19d75b9d1-0cf6-f424-e053-dadaa90a57ceTizanidine Tablets USP
52959-691-602020-01-31C16284748780-19d75b9d1-0cf6-f424-e053-dadaa90a57ceTizanidine Tablets USP
52959-691-632020-01-31C16284748780-19d75b9d1-0cf6-f424-e053-dadaa90a57ceTizanidine Tablets USP
52959-691-902020-01-31C16284748780-19d75b9d1-0cf6-f424-e053-dadaa90a57ceTizanidine Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-691-00Tizanidine100 in 1 BOTTLETABLET1003
52959-691-02Tizanidine120 in 1 BOTTLETABLET1203
52959-691-05Tizanidine150 in 1 BOTTLETABLET1503
52959-691-20Tizanidine20 in 1 BOTTLETABLET203
52959-691-24Tizanidine24 in 1 BOTTLETABLET243
52959-691-25Tizanidine25 in 1 BOTTLETABLET253
52959-691-30Tizanidine30 in 1 BOTTLETABLET303
52959-691-45Tizanidine45 in 1 BOTTLETABLET453
52959-691-60Tizanidine60 in 1 BOTTLETABLET603
52959-691-63Tizanidine63 in 1 BOTTLETABLET633
52959-691-90Tizanidine90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-691-00EA - Each52959-691fed12ccf-0367-4265-86e1-62e36863015812012-07-24
52959-691-02EA - Each52959-6914e1bb51b-f5c7-44dd-ab11-e2560c9e6ee812012-07-24
52959-691-05EA - Each52959-69140b56d86-8f65-4ca9-999e-5a2bb9b4292512012-07-24
52959-691-20EA - Each52959-69194abc374-4223-4967-8813-234560b7dbc312012-07-24
52959-691-24EA - Each52959-6915f8e4707-69cd-45e7-9aaf-f6585dc16a9112012-07-24
52959-691-25EA - Each52959-6916fdad8dc-7df9-44d3-ba02-2d627e53062c12012-07-24
52959-691-30EA - Each52959-69188d9d159-7485-479e-b5fd-b46c8d9505c412012-07-24
52959-691-45EA - Each52959-691617acbbd-b5ca-4d20-9d2f-44f54266b27412012-07-24
52959-691-60EA - Each52959-691d95be4a5-f2e3-48a9-aab2-86842a76638812012-07-24
52959-691-63EA - Each52959-691c66b9cba-25ed-4b6a-bf1c-03ebc1baaa5312012-07-24
52959-691-90EA - Each52959-69115fb3475-4ccd-4fdb-87fa-84cf2dae011f12012-07-24

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
52959-691TIZANIDINE TABLET [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 11 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
52959-691-0052959069100100 in 1 BOTTLEHistorical
52959-691-0252959069102120 in 1 BOTTLEHistorical
52959-691-0552959069105150 in 1 BOTTLEHistorical
52959-691-205295906912020 in 1 BOTTLEHistorical
52959-691-245295906912424 in 1 BOTTLEHistorical
52959-691-255295906912525 in 1 BOTTLEHistorical
52959-691-305295906913030 in 1 BOTTLEHistorical
52959-691-455295906914545 in 1 BOTTLEHistorical
52959-691-605295906916060 in 1 BOTTLEHistorical
52959-691-635295906916363 in 1 BOTTLEHistorical
52959-691-905295906919090 in 1 BOTTLEHistorical