Tizanidine
These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
204984ed-771c-4249-bba5-50d51c60e901
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2017
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tizanidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50436-6756
Application NumberANDA076286
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tizanidine
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2017
FDA Product Classification
INGREDIENTS (5)
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
TIZANIDINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT