Tizanidine
These highlights do not include all the information needed to use Tizanidine Tablets, USP safely and effectively. See full prescribing information for Tizanidine Tablets, USP. Tizanidine Tablets, USP (tizanidine hydrochloride) tablets, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
f32f399f-42af-f0ba-e053-2a95a90a8c2e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2023
Manufacturers
FDA
Northwind Pharmaceuticals, LLC
DUNS: 036986393
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 Code51655-740
Application NumberANDA076416
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 26, 2023
Generic NameTizanidine
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TIZANIDINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIM