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
3736d691-e8b9-4fdd-aeca-9e96cf907c51
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 4
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 Code54868-5412
Application NumberNDA020667
Product Classification
M
Marketing Category
C73594
G
Generic Name
pramipexole dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2011
FDA Product Classification
INGREDIENTS (6)
pramipexole dihydrochlorideActive
Quantity: 0.500 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
pramipexole dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5746
Application NumberNDA020667
Product Classification
M
Marketing Category
C73594
G
Generic Name
pramipexole dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2011
FDA Product Classification
INGREDIENTS (6)
pramipexole dihydrochlorideActive
Quantity: 1 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
pramipexole dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4211
Application NumberNDA020667
Product Classification
M
Marketing Category
C73594
G
Generic Name
pramipexole dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2011
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
pramipexole dihydrochlorideActive
Quantity: 0.250 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
pramipexole dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4912
Application NumberNDA020667
Product Classification
M
Marketing Category
C73594
G
Generic Name
pramipexole dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2011
FDA Product Classification
INGREDIENTS (6)
pramipexole dihydrochlorideActive
Quantity: 0.125 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT