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
b68a9f81-7138-48cf-b987-b8d284e8105a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2023
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tizanidine
PRODUCT DETAILS
NDC Product Code35356-662
Application NumberANDA076286
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 15, 2021
Generic NameTizanidine
INGREDIENTS (5)
Tizanidine HydrochlorideActive
Quantity: 2 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIM
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT