tizanidine

Product NDC
50090-7716
11-digit product format
500907716
Labeler code
50090
Product ID
50090-7716_9edb8ad4-7e86-4eb9-b5b9-466b466c3fe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA218920
Marketing category
ANDA
Marketing start
2024-12-15
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
2 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 HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412

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
50090-7716-0tizanidine30 in 1 BOTTLETABLET301
50090-7716-1tizanidine60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7716-0EA - Each50090-7716e0217ca2-6071-4b1b-8540-7409272dee9f12025-12-16
50090-7716-1EA - Each50090-77163dd53c12-3ae1-4317-a749-c0e26b8e353512025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN52830423-0430-410e-93af-169dc11b35651
313412tizanidine 2 MG Oral TabletSCD52830423-0430-410e-93af-169dc11b35651
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY52830423-0430-410e-93af-169dc11b35651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7716-05009077160030 TABLET in 1 BOTTLE (50090-7716-0) 30 tablet2025-10-15NoNoCurrent
50090-7716-15009077160160 TABLET in 1 BOTTLE (50090-7716-1) 60 tablet2025-10-15NoNoCurrent