Pramipexole Dihydrochloride
Approved
Approval ID
2cfedf7a-8ec2-4060-a4cf-305c06e03192
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2012
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 Code54868-6159
Application NumberANDA077724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2012
FDA Product Classification
INGREDIENTS (4)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.25 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6237
Application NumberANDA077724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2012
FDA Product Classification
INGREDIENTS (4)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.125 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6121
Application NumberANDA077724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2012
FDA Product Classification
INGREDIENTS (4)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6111
Application NumberANDA077724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2012
FDA Product Classification
INGREDIENTS (4)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT