tizanidine

Product NDC
63187-145
11-digit product format
631870145
Labeler code
63187
Product ID
63187-145_fa1c80fd-e646-4850-8f31-04c5417978c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076533
Marketing category
ANDA
Marketing start
2004-01-16
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
63187-145-30tizanidine30 in 1 BOTTLETABLET306
63187-145-60tizanidine60 in 1 BOTTLETABLET606
63187-145-90tizanidine90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-145TIZANIDINE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20220726_cf77e63c-a62a-43fc-8705-0558925e04e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNcf77e63c-a62a-43fc-8705-0558925e04e86
313413tizanidine 4 MG Oral TabletSCDcf77e63c-a62a-43fc-8705-0558925e04e86
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYcf77e63c-a62a-43fc-8705-0558925e04e86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-145-306318701453030 TABLET in 1 BOTTLE (63187-145-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-145-606318701456060 TABLET in 1 BOTTLE (63187-145-60) 60 tablet2019-01-010000-00-00NoNoCurrent
63187-145-906318701459090 TABLET in 1 BOTTLE (63187-145-90) 90 tablet2019-01-010000-00-00NoNoCurrent