FDA.reportPublic FDA data

tizanidine

Product NDC
60505-0252
11-digit product format
605050252
Labeler code
60505
Product ID
60505-0252_95820c11-e6e2-4f26-6af9-2cc60ef94c41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
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
Rxcui313412, 313413

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
60505-0252-1tizanidine100 in 1 BOTTLETABLET10014
60505-0252-2tizanidine1000 in 1 BOTTLETABLET100014
60505-0252-3tizanidine150 in 1 BOTTLETABLET15014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0252-2EA - Each60505-02524276ec64-b099-4123-aeaa-5a71f94becfe12012-07-24
60505-0252-3EA - Each60505-02529825609a-364d-4941-b4d7-cf529ce9374512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [APOTEX CORP.]5
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [APOTEX CORP.]5
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [APOTEX CORP.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [APOTEX CORP.]5
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [APOTEX CORP.]5
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [APOTEX CORP.]5
tizanidine hydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [PROFICIENT RX LP]3
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [PROFICIENT RX LP]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [PROFICIENT RX LP]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [PROFICIENT RX LP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [PROFICIENT RX LP]3
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [PROFICIENT RX LP]3
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]2
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [DIRECT RX]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [DIRECT RX]2
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [DIRECT RX]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [DIRECT RX]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [DIRECT RX]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0252TIZANIDINE TABLET [APOTEX CORP.]14Current NDC, Legacy NDC, 3 package rows20250313_01c0d3d3-2373-a1b7-822a-80a66291a248.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN01c0d3d3-2373-a1b7-822a-80a66291a24814
313413tiZANidine HCl 4 MG Oral TabletPSN01c0d3d3-2373-a1b7-822a-80a66291a24814
313412tizanidine 2 MG Oral TabletSCD01c0d3d3-2373-a1b7-822a-80a66291a24814
313413tizanidine 4 MG Oral TabletSCD01c0d3d3-2373-a1b7-822a-80a66291a24814
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY01c0d3d3-2373-a1b7-822a-80a66291a24814
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY01c0d3d3-2373-a1b7-822a-80a66291a24814
313413tiZANidine HCl 4 MG Oral TabletPSNd24e0cda-a22f-404f-b861-f85090cef09912
313413tizanidine 4 MG Oral TabletSCDd24e0cda-a22f-404f-b861-f85090cef09912
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYd24e0cda-a22f-404f-b861-f85090cef09912
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
313412tiZANidine HCl 2 MG Oral TabletPSN95c5c9b1-43fe-488d-898b-76663f14768a4
313413tiZANidine HCl 4 MG Oral TabletPSNef7673f4-e0c1-4d79-af36-2f2ed2cc28f74
313413tiZANidine HCl 4 MG Oral TabletPSN95c5c9b1-43fe-488d-898b-76663f14768a4
313413tiZANidine HCl 4 MG Oral TabletPSN6a9c62c6-56ce-775e-e053-2991aa0ac9224
313412tizanidine 2 MG Oral TabletSCD95c5c9b1-43fe-488d-898b-76663f14768a4
313413tizanidine 4 MG Oral TabletSCDef7673f4-e0c1-4d79-af36-2f2ed2cc28f74
313413tizanidine 4 MG Oral TabletSCD95c5c9b1-43fe-488d-898b-76663f14768a4
313413tizanidine 4 MG Oral TabletSCD6a9c62c6-56ce-775e-e053-2991aa0ac9224
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY95c5c9b1-43fe-488d-898b-76663f14768a4
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY6a9c62c6-56ce-775e-e053-2991aa0ac9224
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY95c5c9b1-43fe-488d-898b-76663f14768a4
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYef7673f4-e0c1-4d79-af36-2f2ed2cc28f74
313412tiZANidine HCl 2 MG Oral TabletPSN54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tiZANidine HCl 4 MG Oral TabletPSN87ea1003-107e-4bc1-abd4-34977664c4072
313413tiZANidine HCl 4 MG Oral TabletPSNf0e4eb26-6733-4df6-bb3c-86bf4d976f422
313413tiZANidine HCl 4 MG Oral TabletPSN54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tiZANidine HCl 4 MG Oral TabletPSN4e2fd72f-4e76-411c-9ab8-441547141b342
313412tizanidine 2 MG Oral TabletSCD54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tizanidine 4 MG Oral TabletSCD87ea1003-107e-4bc1-abd4-34977664c4072
313413tizanidine 4 MG Oral TabletSCD54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tizanidine 4 MG Oral TabletSCDf0e4eb26-6733-4df6-bb3c-86bf4d976f422
313413tizanidine 4 MG Oral TabletSCD4e2fd72f-4e76-411c-9ab8-441547141b342
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYf0e4eb26-6733-4df6-bb3c-86bf4d976f422
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY87ea1003-107e-4bc1-abd4-34977664c4072
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY4e2fd72f-4e76-411c-9ab8-441547141b342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0252-160505025201100 TABLET in 1 BOTTLE (60505-0252-1) 100 tablet2004-01-160000-00-00NoNoCurrent
60505-0252-2605050252021000 TABLET in 1 BOTTLE (60505-0252-2) 1000 tablet2004-01-160000-00-00NoNoCurrent
60505-0252-360505025203150 TABLET in 1 BOTTLE (60505-0252-3) 150 tablet2004-01-160000-00-00NoNoCurrent