CARBIDOPA AND LEVODOPA- carbidopa and levodopa tablet 
Zydus Lifesciences Limited

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Carbidopa and Levodopa Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1694-1

Carbidopa and Levodopa Tablets, USP 10 mg/100 mg

100 Tablets

Rx only

10 mg/100 mg label

NDC 70771-1695-1

Carbidopa and Levodopa Tablets, USP 25 mg/100 mg

100 Tablets

Rx only

25 mg/100 mg label

NDC 70771-1696-1

Carbidopa and Levodopa Tablets, USP 25 mg/250 mg

100 Tablets

Rx only

25 mg/250 mg label
CARBIDOPA AND LEVODOPA 
carbidopa and levodopa tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1694
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) CARBIDOPA ANHYDROUS10 mg
LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J) LEVODOPA100 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorBLUE (light blue) Score2 pieces
ShapeROUND (round) Size8mm
FlavorImprint Code 1721
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1694-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/24/202403/27/2025
2NDC:70771-1694-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/24/202403/27/2025
3NDC:70771-1694-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/24/202403/27/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21599908/24/202403/27/2025
CARBIDOPA AND LEVODOPA 
carbidopa and levodopa tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1695
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) CARBIDOPA ANHYDROUS25 mg
LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J) LEVODOPA100 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (light yellow) Score2 pieces
ShapeROUND (round) Size8mm
FlavorImprint Code 1722
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1695-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/24/202403/27/2025
2NDC:70771-1695-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/24/202403/27/2025
3NDC:70771-1695-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/24/202403/27/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21599908/24/202403/27/2025
CARBIDOPA AND LEVODOPA 
carbidopa and levodopa tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1696
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) CARBIDOPA ANHYDROUS25 mg
LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J) LEVODOPA250 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorBLUE (light blue) Score2 pieces
ShapeROUND (round) Size10mm
FlavorImprint Code 1723
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1696-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/24/202403/27/2025
2NDC:70771-1696-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/24/202403/27/2025
3NDC:70771-1696-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/24/202403/27/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21599908/24/202403/27/2025
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1694, 70771-1695, 70771-1696) , MANUFACTURE(70771-1694, 70771-1695, 70771-1696)

Revised: 3/2025
Document Id: 4858510a-e363-4322-9b37-2d7da4b212be
Set id: 54c08e94-c97b-4717-adfc-ea12083dbb41
Version: 3
Effective Time: 20250327
 
Zydus Lifesciences Limited