FDA.reportPublic FDA data

tizanidine

Product NDC
60505-0251
11-digit product format
605050251
Labeler code
60505
Product ID
60505-0251_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
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, 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
60505-0251-1tizanidine100 in 1 BOTTLETABLET10014
60505-0251-2tizanidine1000 in 1 BOTTLETABLET100014
60505-0251-3tizanidine150 in 1 BOTTLETABLET15014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0251-2EA - Each60505-0251e0f3dc20-593d-4ac7-83b4-6c6f7d93a52312012-07-24
60505-0251-3EA - Each60505-0251d976963b-4a04-441d-95c7-b88875d1601d12012-07-24

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 [BLENHEIM PHARMACAL, INC.]4
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]4
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [DIRECT RX]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [DIRECT RX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [DIRECT RX]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [DIRECT RX]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [DIRECT RX]2
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0251TIZANIDINE 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
313412tiZANidine HCl 2 MG Oral TabletPSN95c5c9b1-43fe-488d-898b-76663f14768a4
313412tiZANidine HCl 2 MG Oral TabletPSN10457e1d-068f-7071-e054-00144ff8d46c4
313413tiZANidine HCl 4 MG Oral TabletPSN95c5c9b1-43fe-488d-898b-76663f14768a4
313412tizanidine 2 MG Oral TabletSCD10457e1d-068f-7071-e054-00144ff8d46c4
313412tizanidine 2 MG Oral TabletSCD95c5c9b1-43fe-488d-898b-76663f14768a4
313413tizanidine 4 MG Oral TabletSCD95c5c9b1-43fe-488d-898b-76663f14768a4
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY10457e1d-068f-7071-e054-00144ff8d46c4
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 TabletSY95c5c9b1-43fe-488d-898b-76663f14768a4
313412tiZANidine HCl 2 MG Oral TabletPSN54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tiZANidine HCl 4 MG Oral TabletPSN54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313412tizanidine 2 MG Oral TabletSCD54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tizanidine 4 MG Oral TabletSCD54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
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 TabletSY54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313412tiZANidine HCl 2 MG Oral TabletPSN1fe204a5-8ca8-1fa1-e054-00144ff8d46c1
313412tiZANidine HCl 2 MG Oral TabletPSNd3b8d863-d13d-467c-97bf-5db9708036db1
313412tizanidine 2 MG Oral TabletSCD1fe204a5-8ca8-1fa1-e054-00144ff8d46c1
313412tizanidine 2 MG Oral TabletSCDd3b8d863-d13d-467c-97bf-5db9708036db1
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY1fe204a5-8ca8-1fa1-e054-00144ff8d46c1
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYd3b8d863-d13d-467c-97bf-5db9708036db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0251-160505025101100 TABLET in 1 BOTTLE (60505-0251-1) 100 tablet2004-01-160000-00-00NoNoCurrent
60505-0251-2605050251021000 TABLET in 1 BOTTLE (60505-0251-2) 1000 tablet2004-01-160000-00-00NoNoCurrent
60505-0251-360505025103150 TABLET in 1 BOTTLE (60505-0251-3) 150 tablet2004-01-160000-00-00NoNoCurrent