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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-493-14EA - Each63187-49365f04472-56ad-4d93-8dce-a67533d7c22312024-04-05
63187-493-15EA - Each63187-493aba949f8-4294-4df1-90bb-395118ca389412019-04-11
63187-493-30EA - Each63187-4937e133747-3839-40ab-bde3-c4a5b7aeda0812015-10-02
63187-493-60EA - Each63187-493d2081563-4d47-48e3-a12c-28e7dbffda8f12016-04-04
63187-493-90EA - Each63187-493120e07b2-2018-4778-95ae-3a0181891f8d12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [PROFICIENT RX LP]1
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [PROFICIENT RX LP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [PROFICIENT RX LP]1

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 tablet2024-02-13NoNoHistorical
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