FDA.reportPublic FDA data

Tizanidine Hydrochloride

Product NDC
42291-811
11-digit product format
422910811
Labeler code
42291
Product ID
42291-811_423ead2f-fbbc-830d-e063-6294a90aacfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine Hydrochloride
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA078868
Marketing category
ANDA
Marketing start
2014-06-20
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
42291-811-15Tizanidine Hydrochloride150 in 1 BOTTLECAPSULE, GELATIN COATED1509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-811-15EA - Each42291-8112643ca56-d3a5-4a80-9261-8bc43bd452b712014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
42291-811TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE]8Current NDC, Legacy NDC, 1 package rows20240405_acc8f9f6-ceb6-0505-8f11-fd7e1f105af3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
42291-811-1542291081115150 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-811-15) 2014-06-200000-00-00NoNoCurrent