Tizanidine
Tizanidine Tablets USP
Approved
Approval ID
6d8e0262-5ccf-4447-90dd-f5eec069664c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 2
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 Code52959-691
Application NumberANDA076286
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tizanidine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2011
FDA Product Classification
INGREDIENTS (5)
Tizanidine HydrochlorideActive
Quantity: 2 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIM
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
Tizanidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-689
Application NumberANDA076286
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tizanidine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2011
FDA Product Classification
INGREDIENTS (5)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
Tizanidine HydrochlorideActive
Quantity: 4 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIM
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT