Droxidopa
These highlights do not include all the information needed to use DROXIDOPA CAPSULES safely and effectively. See full prescribing information for DROXIDOPA CAPSULES. DROXIDOPA capsules, for oral useInitial U.S. Approval: 2014
Approved
Approval ID
aa3ce55a-1ea9-4b50-b682-6f25398bcc29
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Droxidopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1390
Application NumberANDA211818
Product Classification
M
Marketing Category
C73584
G
Generic Name
Droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2023
FDA Product Classification
INGREDIENTS (14)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
DROXIDOPAActive
Quantity: 200 mg in 1 1
Code: J7A92W69L7
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Droxidopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1389
Application NumberANDA211818
Product Classification
M
Marketing Category
C73584
G
Generic Name
Droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2023
FDA Product Classification
INGREDIENTS (14)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DROXIDOPAActive
Quantity: 100 mg in 1 1
Code: J7A92W69L7
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Droxidopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1391
Application NumberANDA211818
Product Classification
M
Marketing Category
C73584
G
Generic Name
Droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2023
FDA Product Classification
INGREDIENTS (14)
DROXIDOPAActive
Quantity: 300 mg in 1 1
Code: J7A92W69L7
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT