FDA.reportPublic FDA data

Tizanidine

Product NDC
53217-211
11-digit product format
532170211
Labeler code
53217
Product ID
53217-211_e000ff99-a782-4438-a5d2-98a74b96b03a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076416
Marketing category
ANDA
Marketing start
2003-12-11
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
No
Listing certified through
2019-12-31
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
53217-211-022020-01-31C16284748780-19d75b9d1-1f38-f424-e053-dadaa90a57ceTizanidine Tablets, Label These highlights do not include all the information needed to use See full prescribing information for Initial U.S. Approval: 1996
53217-211-042020-01-31C16284748780-19d75b9d1-1f38-f424-e053-dadaa90a57ceTizanidine Tablets, Label These highlights do not include all the information needed to use See full prescribing information for Initial U.S. Approval: 1996
53217-211-152020-01-31C16284748780-19d75b9d1-1f38-f424-e053-dadaa90a57ceTizanidine Tablets, Label These highlights do not include all the information needed to use See full prescribing information for Initial U.S. Approval: 1996
53217-211-302020-01-31C16284748780-19d75b9d1-1f38-f424-e053-dadaa90a57ceTizanidine Tablets, Label These highlights do not include all the information needed to use See full prescribing information for Initial U.S. Approval: 1996
53217-211-602020-01-31C16284748780-19d75b9d1-1f38-f424-e053-dadaa90a57ceTizanidine Tablets, Label These highlights do not include all the information needed to use See full prescribing information for Initial U.S. Approval: 1996
53217-211-902020-01-31C16284748780-19d75b9d1-1f38-f424-e053-dadaa90a57ceTizanidine Tablets, Label These highlights do not include all the information needed to use See full prescribing information for Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-211-02Tizanidine120 in 1 BOTTLETABLET1201
53217-211-04Tizanidine240 in 1 BOTTLETABLET2401
53217-211-15Tizanidine15 in 1 BOTTLETABLET151
53217-211-30Tizanidine150 in 1 BOTTLETABLET1501
53217-211-60Tizanidine60 in 1 BOTTLETABLET601
53217-211-90Tizanidine90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-211TIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 6 package rows20161210_d646e3e1-d611-4c23-9ded-b327e4acfe4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNd646e3e1-d611-4c23-9ded-b327e4acfe4f1
313413tizanidine 4 MG Oral TabletSCDd646e3e1-d611-4c23-9ded-b327e4acfe4f1
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYd646e3e1-d611-4c23-9ded-b327e4acfe4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-211-0253217021102120 in 1 BOTTLEHistorical
53217-211-0453217021104240 in 1 BOTTLEHistorical
53217-211-155321702111515 in 1 BOTTLEHistorical
53217-211-3053217021130150 in 1 BOTTLEHistorical
53217-211-605321702116060 in 1 BOTTLEHistorical
53217-211-905321702119090 in 1 BOTTLEHistorical