PRAMIPEXOLE DIHYDROCHLORIDE- pramipexole dihydrochloride tablet 
Cadila Healthcare Limited

----------

PRAMIPEXOLE DIHYDROCHLORIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-734-16 in bottle of 90 tablets

Pramipexole Dihydrochloride Tablets, 0.125 mg

Rx only

90 tablets

Pramipexole Dihydrochloride Tablets, 0.125 mg

NDC 65841-735-16 in bottle of 90 tablets

Pramipexole Dihydrochloride Tablets, 0.25 mg

Rx only

90 tablets

Pramipexole Dihydrochloride Tablets, 0.25 mg

NDC 65841-736-16 in bottle of 90 tablets

Pramipexole Dihydrochloride Tablets, 0.5 mg

Rx only

90 tablets

Pramipexole Dihydrochloride Tablets , 0.5 mg

NDC 65841-737-16 in bottle of 90 tablets

Pramipexole Dihydrochloride Tablets, 1 mg

Rx only

90 tablets

Pramipexole Dihydrochloride Tablets , 1 mg

NDC 65841-738-16 in bottle of 90 tablets

Pramipexole Dihydrochloride Tablets, 1.5 mg

Rx only

90 tablets

Pramipexole Dihydrochloride Tablets , 1.5 mmg
PRAMIPEXOLE DIHYDROCHLORIDE 
pramipexole dihydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-734
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE0.125 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorPINK (PINK) Scoreno score
ShapeCAPSULE (CAPSULE) Size7mm
FlavorImprint Code P1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-734-1690 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
2NDC:65841-734-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
3NDC:65841-734-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07892007/10/2010
PRAMIPEXOLE DIHYDROCHLORIDE 
pramipexole dihydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-735
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE0.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorBLUE (PALE BLUE) Score2 pieces
ShapeROUND (ROUND) Size6mm
FlavorImprint Code P2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-735-1690 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
2NDC:65841-735-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
3NDC:65841-735-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07892007/10/2010
PRAMIPEXOLE DIHYDROCHLORIDE 
pramipexole dihydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-736
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE0.5 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorPURPLE (LAVENDER) Score2 pieces
ShapeCAPSULE (CAPSULE) Size8mm
FlavorImprint Code P;3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-736-1690 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
2NDC:65841-736-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
3NDC:65841-736-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07892007/10/2010
PRAMIPEXOLE DIHYDROCHLORIDE 
pramipexole dihydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-737
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE1 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorORANGE (LIGHT PEACH TO PEACH) Score2 pieces
ShapeROUND (ROUND) Size6mm
FlavorImprint Code P4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-737-1690 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
2NDC:65841-737-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
3NDC:65841-737-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07892007/10/2010
PRAMIPEXOLE DIHYDROCHLORIDE 
pramipexole dihydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-738
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE1.5 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorYELLOW (YELLOW) Score2 pieces
ShapeROUND (ROUND) Size7mm
FlavorImprint Code P5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-738-1690 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
2NDC:65841-738-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
3NDC:65841-738-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07892007/10/2010
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-734, 65841-735, 65841-736, 65841-737, 65841-738) , MANUFACTURE(65841-734, 65841-735, 65841-736, 65841-737, 65841-738)

Revised: 9/2020
Document Id: d9a31cd3-4a42-4704-8855-ccf846efdf74
Set id: 0ac104bc-8ee9-4602-b1b3-38521342f97c
Version: 7
Effective Time: 20200908
 
Cadila Healthcare Limited