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
381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2020
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Droxidopa
PRODUCT DETAILS
NDC Product Code72205-074
Application NumberANDA211741
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 20, 2020
Generic NameDroxidopa
INGREDIENTS (12)
DROXIDOPAActive
Quantity: 300 mg in 1 1
Code: J7A92W69L7
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Droxidopa
PRODUCT DETAILS
NDC Product Code72205-073
Application NumberANDA211741
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 20, 2020
Generic NameDroxidopa
INGREDIENTS (11)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
DROXIDOPAActive
Quantity: 200 mg in 1 1
Code: J7A92W69L7
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Droxidopa
PRODUCT DETAILS
NDC Product Code72205-072
Application NumberANDA211741
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 20, 2020
Generic NameDroxidopa
INGREDIENTS (12)
DROXIDOPAActive
Quantity: 100 mg in 1 1
Code: J7A92W69L7
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Drug Labeling Information
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 11/20/2020
4 CONTRAINDICATIONS
Droxidopa is contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients [see Warnings and Precautions (5.4)].
Key Highlight
History of hypersensitivity to the drug or its ingredients (4)