TIZANIDINE HYDROCHLORIDE
Tizanidine hydrochloride Tablets
Approved
Approval ID
0df212f5-f77b-4d94-8fd0-0b40d0e9a1c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 7, 2010
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
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 Code68387-140
Application NumberANDA076347
Product Classification
M
Marketing Category
C73584
G
Generic Name
TIZANIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2010
FDA Product Classification
INGREDIENTS (6)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TIZANIDINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TIZANIDINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68387-130
Application NumberANDA076347
Product Classification
M
Marketing Category
C73584
G
Generic Name
TIZANIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2010
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TIZANIDINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT