ZANAFLEX
Approved
Approval ID
939d9fec-727e-488e-adc4-cc941292b23e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2011
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 Code16590-871
Application NumberNDA021447
Product Classification
M
Marketing Category
C73594
G
Generic Name
TIZANIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2011
FDA Product Classification
INGREDIENTS (5)
HYDROXYMETHYL CELLULOSEInactive
Code: 273FM27VK1
Classification: IACT
TIZANIDINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TIZANIDINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-756
Application NumberNDA021447
Product Classification
M
Marketing Category
C73594
G
Generic Name
TIZANIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2011
FDA Product Classification
INGREDIENTS (5)
TIZANIDINE HYDROCHLORIDEActive
Quantity: 6 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIB
HYDROXYMETHYL CELLULOSEInactive
Code: 273FM27VK1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT