FDA.reportPublic FDA data

Tizanidine

Product NDC
50090-6756
11-digit product format
500906756
Labeler code
50090
Product ID
50090-6756_4ccf302b-0c01-4e14-81a5-2904b7116e78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076286
Marketing category
ANDA
Marketing start
2021-06-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2026-12-31

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
50090-6756-0Tizanidine120 in 1 BOTTLETABLET1201
50090-6756-2Tizanidine60 in 1 BOTTLETABLET601
50090-6756-3Tizanidine15 in 1 BOTTLETABLET151
50090-6756-4Tizanidine30 in 1 BOTTLETABLET301
50090-6756-6Tizanidine90 in 1 BOTTLETABLET901
50090-6756-7Tizanidine14 in 1 BOTTLETABLET141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6756TIZANIDINE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 6 package rows20231019_67b2af93-92c9-4c33-8fa0-548bfcc9c538.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN67b2af93-92c9-4c33-8fa0-548bfcc9c5381
313413tizanidine 4 MG Oral TabletSCD67b2af93-92c9-4c33-8fa0-548bfcc9c5381
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY67b2af93-92c9-4c33-8fa0-548bfcc9c5381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6756-050090675600120 TABLET in 1 BOTTLE (50090-6756-0) 120 tablet2023-10-17NoNoHistorical
50090-6756-25009067560260 TABLET in 1 BOTTLE (50090-6756-2) 60 tablet2023-10-17NoNoHistorical
50090-6756-35009067560315 TABLET in 1 BOTTLE (50090-6756-3) 15 tablet2023-10-17NoNoHistorical
50090-6756-45009067560430 TABLET in 1 BOTTLE (50090-6756-4) 30 tablet2023-10-17NoNoHistorical
50090-6756-65009067560690 TABLET in 1 BOTTLE (50090-6756-6) 90 tablet2023-10-17NoNoHistorical
50090-6756-75009067560714 TABLET in 1 BOTTLE (50090-6756-7) 14 tablet2023-10-17NoNoHistorical