FDA.reportPublic FDA data

Tizanidine Hydrochloride

Product NDC
60505-2649
11-digit product format
605052649
Labeler code
60505
Product ID
60505-2649_f68c762c-26fc-7c61-1a94-6b5110937eea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine Hydrochloride
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA078868
Marketing category
ANDA
Marketing start
2012-02-06
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485484, 485485, 485486

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
60505-2649-0Tizanidine Hydrochloride10 in 1 CARTONCAPSULE, GELATIN COATED1012
60505-2649-0Tizanidine Hydrochloride10 in 1 BLISTER PACKCAPSULE, GELATIN COATED1012
60505-2649-3Tizanidine Hydrochloride30 in 1 BOTTLECAPSULE, GELATIN COATED3012
60505-2649-7Tizanidine Hydrochloride150 in 1 BOTTLECAPSULE, GELATIN COATED15012
60505-2649-8Tizanidine Hydrochloride1000 in 1 BOTTLECAPSULE, GELATIN COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2649-7EA - Each60505-26490874535d-a16c-4490-86cc-45e3612f32b612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
GELATININACTIVE INGREDIENT2G86QN327LTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
SHELLACINACTIVE INGREDIENT46N107B71OTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]3
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [AVKARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2649TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [APOTEX CORP.]11Current NDC, Legacy NDC, 5 package rows20241224_3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485486tiZANidine HCl 2 MG Oral CapsulePSN3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe12
485485tiZANidine HCl 4 MG Oral CapsulePSN3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe12
485484tiZANidine HCl 6 MG Oral CapsulePSN3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe12
485486tizanidine 2 MG Oral CapsuleSCD3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe12
485485tizanidine 4 MG Oral CapsuleSCD3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe12
485484tizanidine 6 MG Oral CapsuleSCD3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe12
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSY3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe12
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe12
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe12
485486tiZANidine HCl 2 MG Oral CapsulePSNacc8f9f6-ceb6-0505-8f11-fd7e1f105af39
485485tiZANidine HCl 4 MG Oral CapsulePSNacc8f9f6-ceb6-0505-8f11-fd7e1f105af39
485484tiZANidine HCl 6 MG Oral CapsulePSNacc8f9f6-ceb6-0505-8f11-fd7e1f105af39
485486tizanidine 2 MG Oral CapsuleSCDacc8f9f6-ceb6-0505-8f11-fd7e1f105af39
485485tizanidine 4 MG Oral CapsuleSCDacc8f9f6-ceb6-0505-8f11-fd7e1f105af39
485484tizanidine 6 MG Oral CapsuleSCDacc8f9f6-ceb6-0505-8f11-fd7e1f105af39
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSYacc8f9f6-ceb6-0505-8f11-fd7e1f105af39
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYacc8f9f6-ceb6-0505-8f11-fd7e1f105af39
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYacc8f9f6-ceb6-0505-8f11-fd7e1f105af39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-2649-06050526490010 in 1 CARTONHistorical
60505-2649-36050526490330 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2649-3) 2012-02-060000-00-00NoNoCurrent
60505-2649-760505264907150 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2649-7) 2012-02-060000-00-00NoNoCurrent
60505-2649-8605052649081000 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2649-8) 2012-02-060000-00-00NoNoCurrent