FDA.reportPublic FDA data

Tizanidine

Product NDC
50090-5767
11-digit product format
500905767
Labeler code
50090
Product ID
50090-5767_e68d46ad-efb1-4422-9320-154acf969626
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091283
Marketing category
ANDA
Marketing start
2013-04-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313413

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5767-0Tizanidine120 in 1 BOTTLETABLET1207
50090-5767-2Tizanidine60 in 1 BOTTLETABLET607
50090-5767-3Tizanidine15 in 1 BOTTLETABLET157
50090-5767-4Tizanidine30 in 1 BOTTLETABLET307
50090-5767-6Tizanidine90 in 1 BOTTLETABLET907
50090-5767-7Tizanidine14 in 1 BOTTLETABLET147

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5767TIZANIDINE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 6 package rows20231204_308d2fdc-6136-4e75-95d3-342497add66c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN308d2fdc-6136-4e75-95d3-342497add66c7
313413tizanidine 4 MG Oral TabletSCD308d2fdc-6136-4e75-95d3-342497add66c7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY308d2fdc-6136-4e75-95d3-342497add66c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5767-050090576700120 TABLET in 1 BOTTLE (50090-5767-0) 120 tablet2021-10-040000-00-00NoNoCurrent
50090-5767-25009057670260 TABLET in 1 BOTTLE (50090-5767-2) 60 tablet2021-10-040000-00-00NoNoCurrent
50090-5767-35009057670315 TABLET in 1 BOTTLE (50090-5767-3) 15 tablet2021-10-040000-00-00NoNoCurrent
50090-5767-45009057670430 TABLET in 1 BOTTLE (50090-5767-4) 30 tablet2021-10-040000-00-00NoNoCurrent
50090-5767-65009057670690 TABLET in 1 BOTTLE (50090-5767-6) 90 tablet2021-10-040000-00-00NoNoCurrent
50090-5767-75009057670714 TABLET in 1 BOTTLE (50090-5767-7) 14 tablet2021-10-040000-00-00NoNoCurrent