ROPINIROLE HYDROCHLORIDE- ropinirole hydrochloride tablet, film coated 
Cadila Healthcare Limited

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ROPINIROLE TABELTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-712-01 in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 0.25 mg

100 tablets

ropinirole hcl tablets, 0.25 mg

NDC 65841-713-01  in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 0.5 mg

100 tablets

ropinirole hcl tablets, 0.5 mg

NDC 65841-714-01 in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 1 mg

100 tablets

ropinirole hcl tablets, 1 mg

NDC 65841-715-01in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 2 mg

100 tablets

ropinirole hcl tablets, 2 mg

NDC 65841-716-01 in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 3 mg

100 tablets

ropinirole hcl tablets, 3 mg

NDC 65841-717-01 in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 4 mg

100 tablets

ropinirole hcl tablets, 4 mg

NDC 65841-718-01 in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 5 mg

100 tablets

ropinirole hcl tablets, 5 mg
ROPINIROLE HYDROCHLORIDE 
ropinirole hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-712
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE0.25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZF22
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-712-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
2NDC:65841-712-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09041109/23/2009
ROPINIROLE HYDROCHLORIDE 
ropinirole hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-713
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE0.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorYELLOW (YELLOW) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZF23
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-713-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
2NDC:65841-713-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09041109/23/2009
ROPINIROLE HYDROCHLORIDE 
ropinirole hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-714
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE1 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorGREEN (GREEN) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZF24
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-714-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
2NDC:65841-714-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09041109/23/2009
ROPINIROLE HYDROCHLORIDE 
ropinirole hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-715
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE2 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorPINK (PINK) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZF25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-715-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
2NDC:65841-715-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09041109/23/2009
ROPINIROLE HYDROCHLORIDE 
ropinirole hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-716
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE3 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CARMINIC ACID (UNII: CID8Z8N95N)  
Product Characteristics
ColorPURPLE (PURPLE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZF42
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-716-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
2NDC:65841-716-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09041109/23/2009
ROPINIROLE HYDROCHLORIDE 
ropinirole hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-717
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE4 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (BROWN) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZF43
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-717-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
2NDC:65841-717-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09041109/23/2009
ROPINIROLE HYDROCHLORIDE 
ropinirole hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-718
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorBLUE (BLUE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZF26
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-718-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
2NDC:65841-718-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09041109/23/2009
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-712, 65841-713, 65841-714, 65841-715, 65841-716, 65841-717, 65841-718) , MANUFACTURE(65841-712, 65841-713, 65841-714, 65841-715, 65841-716, 65841-717, 65841-718)

Revised: 9/2020
Document Id: f6a754bd-70d6-49b8-a3f9-7051227f7fd5
Set id: 5525c364-3574-4029-89dc-1efc6d85c03c
Version: 6
Effective Time: 20200914
 
Cadila Healthcare Limited