DROXIDOPA - droxidopa capsule 
Zydus Lifesciences Limited

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Droxidopa Capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1609-9

Droxidopa Capsules, 100 mg

90 Capsules

Rx only

Droxi-100mg-image

NDC 70771-1610-9

Droxidopa Capsules, 200 mg

90 Capsules

Rx only

droxi-200mg-image

NDC 70771-1611-9

Droxidopa Capsules, 300 mg

90 Capsules

Rx only

Droxi-300mg-image
DROXIDOPA 
droxidopa capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1609
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DROXIDOPA (UNII: J7A92W69L7) (DROXIDOPA - UNII:J7A92W69L7) DROXIDOPA100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUE (opaque blue cap) , WHITE (opaque white body) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code 1389
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1609-990 in 1 BOTTLE; Type 0: Not a Combination Product02/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21181802/19/2021
DROXIDOPA 
droxidopa capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1610
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DROXIDOPA (UNII: J7A92W69L7) (DROXIDOPA - UNII:J7A92W69L7) DROXIDOPA200 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (opaque yellow cap) , WHITE (opaque white body) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 1390
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1610-990 in 1 BOTTLE; Type 0: Not a Combination Product02/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21181802/19/2021
DROXIDOPA 
droxidopa capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1611
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DROXIDOPA (UNII: J7A92W69L7) (DROXIDOPA - UNII:J7A92W69L7) DROXIDOPA300 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorGREEN (opaque green cap) , WHITE (opaque white body) Scoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 1391
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1611-990 in 1 BOTTLE; Type 0: Not a Combination Product02/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21181802/19/2021
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1609, 70771-1610, 70771-1611) , MANUFACTURE(70771-1609, 70771-1610, 70771-1611)

Revised: 8/2022
Document Id: 1f3d60f8-b73c-459f-8f63-8cd6169a6431
Set id: e9894e44-99ff-471a-bcc2-bfecd55a6559
Version: 2
Effective Time: 20220825
 
Zydus Lifesciences Limited