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 use Initial U.S. Approval: 2014
Approved
Approval ID
10b02d98-ebb8-4152-bd56-3402417fbf79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2021
Manufacturers
FDA
ScieGen Pharmaceuticals Inc
DUNS: 079391286
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 Code50228-429
Application NumberANDA214017
Product Classification
M
Marketing Category
C73584
G
Generic Name
droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2021
FDA Product Classification
INGREDIENTS (9)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DROXIDOPAActive
Quantity: 100 mg in 1 1
Code: J7A92W69L7
Classification: ACTIB
droxidopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-431
Application NumberANDA214017
Product Classification
M
Marketing Category
C73584
G
Generic Name
droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2021
FDA Product Classification
INGREDIENTS (8)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DROXIDOPAActive
Quantity: 300 mg in 1 1
Code: J7A92W69L7
Classification: ACTIB
droxidopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-430
Application NumberANDA214017
Product Classification
M
Marketing Category
C73584
G
Generic Name
droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2021
FDA Product Classification
INGREDIENTS (8)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DROXIDOPAActive
Quantity: 200 mg in 1 1
Code: J7A92W69L7
Classification: ACTIB