FDA.reportPublic FDA data

Tizanidine

Product NDC
63187-493
11-digit product format
631870493
Labeler code
63187
Product ID
63187-493_e7d65f5b-1968-4e65-8693-ae7f34a9c508
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
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
63187-493-14Tizanidine14 in 1 BOTTLE, PLASTICTABLET147
63187-493-15Tizanidine15 in 1 BOTTLE, PLASTICTABLET157
63187-493-30Tizanidine30 in 1 BOTTLE, PLASTICTABLET307
63187-493-60Tizanidine60 in 1 BOTTLE, PLASTICTABLET607
63187-493-90Tizanidine90 in 1 BOTTLE, PLASTICTABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-493TIZANIDINE TABLET [PROFICIENT RX LP]7Current NDC, Legacy NDC, 5 package rows20240216_e13b111a-25b7-4fdd-a102-30f2996722f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNe13b111a-25b7-4fdd-a102-30f2996722f37
313413tizanidine 4 MG Oral TabletSCDe13b111a-25b7-4fdd-a102-30f2996722f37
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYe13b111a-25b7-4fdd-a102-30f2996722f37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-493-146318704931414 TABLET in 1 BOTTLE, PLASTIC (63187-493-14) 14 tablet2024-02-13NoNoCurrent
63187-493-156318704931515 TABLET in 1 BOTTLE, PLASTIC (63187-493-15) 15 tablet2019-01-010000-00-00NoNoCurrent
63187-493-306318704933030 TABLET in 1 BOTTLE, PLASTIC (63187-493-30) 30 tablet2015-02-020000-00-00NoNoCurrent
63187-493-606318704936060 TABLET in 1 BOTTLE, PLASTIC (63187-493-60) 60 tablet2015-02-020000-00-00NoNoCurrent
63187-493-906318704939090 TABLET in 1 BOTTLE, PLASTIC (63187-493-90) 90 tablet2015-02-020000-00-00NoNoCurrent