tizanidine hydrochloride
Tizanidine Hydrochloride Tablets 2 mg and 4 mg
Approved
Approval ID
43d51c1d-5f5b-4b9e-95d0-d12ceff8d84e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tizanidine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-597
Application NumberANDA076280
Product Classification
M
Marketing Category
C73584
G
Generic Name
tizanidine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2012
FDA Product Classification
INGREDIENTS (5)
TIZANIDINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIM
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
tizanidine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-549
Application NumberANDA076280
Product Classification
M
Marketing Category
C73584
G
Generic Name
tizanidine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2012
FDA Product Classification
INGREDIENTS (5)
TIZANIDINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIM
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT