Zanaflex
Zanaflex Capsules Zanaflex Tablets
Approved
Approval ID
b581d63f-61cb-41b6-a7ca-24bd0b32a8ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
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 Code21695-373
Application NumberNDA021447
Product Classification
M
Marketing Category
C73594
G
Generic Name
tizanidine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2008
FDA Product Classification
INGREDIENTS (6)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
tizanidine hydrochlorideActive
Quantity: 4 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT