TIZANIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE
Approved
Approval ID
4f0d83de-0810-4255-8114-443f8fb915de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2009
Manufacturers
FDA
Rebel Distributors
DUNS: 118802834
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 Code21695-126
Application NumberANDA076347
Product Classification
M
Marketing Category
C73584
G
Generic Name
TIZANIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2009
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TIZANIDINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIR
TIZANIDINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-127
Application NumberANDA076347
Product Classification
M
Marketing Category
C73584
G
Generic Name
TIZANIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2009
FDA Product Classification
INGREDIENTS (6)
TIZANIDINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT