Mirapex
Mirapex (pramipexole dihydrochloride) 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg Tablets
Approved
Approval ID
b5504316-3907-444c-b604-ec9a18cdcd6d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 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.
pramipexole dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-867
Application NumberNDA020667
Product Classification
M
Marketing Category
C73594
G
Generic Name
pramipexole dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2009
FDA Product Classification
INGREDIENTS (6)
pramipexole dihydrochlorideActive
Quantity: 0.500 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT