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
51ef3096-4622-4f45-a180-ab0dc6d46df9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 18, 2021
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code63304-086
Application NumberANDA214384
Product Classification
M
Marketing Category
C73584
G
Generic Name
droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2021
FDA Product Classification
INGREDIENTS (10)
DROXIDOPAActive
Quantity: 100 ug in 1 1
Code: J7A92W69L7
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
droxidopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-104
Application NumberANDA214384
Product Classification
M
Marketing Category
C73584
G
Generic Name
droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2021
FDA Product Classification
INGREDIENTS (10)
DROXIDOPAActive
Quantity: 200 ug in 1 1
Code: J7A92W69L7
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
droxidopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-112
Application NumberANDA214384
Product Classification
M
Marketing Category
C73584
G
Generic Name
droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2021
FDA Product Classification
INGREDIENTS (12)
DROXIDOPAActive
Quantity: 300 ug in 1 1
Code: J7A92W69L7
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT