Tizanidine
Tizanidine Tablets USP
Approved
Approval ID
9c70817f-e721-4f04-b095-0747702df614
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2010
Manufacturers
FDA
Altura Pharmaceuticals, Inc.
DUNS: 006890545
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 Code63874-087
Application NumberANDA076286
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tizanidine
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2010
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TIZANIDINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT