Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pramipexole Dihydrochloride
Product Details
NDC Product Code
54868-6159Application Number
ANDA077724Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 3, 2012MANNITOLInactive
Code: 3OWL53L36AClass: IACT
PramipexoleActive
Code: 3D867NP06JClass: ACTIBQuantity: 0.25 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Pramipexole Dihydrochloride
Product Details
NDC Product Code
54868-6237Application Number
ANDA077724Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 3, 2012STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
PramipexoleActive
Code: 3D867NP06JClass: ACTIBQuantity: 0.125 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
Pramipexole Dihydrochloride
Product Details
NDC Product Code
54868-6121Application Number
ANDA077724Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 3, 2012STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
PramipexoleActive
Code: 3D867NP06JClass: ACTIBQuantity: 0.5 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
Pramipexole Dihydrochloride
Product Details
NDC Product Code
54868-6111Application Number
ANDA077724Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 3, 2012PramipexoleActive
Code: 3D867NP06JClass: ACTIBQuantity: 1 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT