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
b419da70-1b11-4fff-ba00-60234bd5d265
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 25, 2023
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 047251004
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 Code0832-0722
Application NumberANDA213661
Product Classification
M
Marketing Category
C73584
G
Generic Name
Droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2019
FDA Product Classification
INGREDIENTS (13)
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
DroxidopaActive
Quantity: 300 mg in 1 1
Code: J7A92W69L7
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
gelatin type b bovine (230 bloom)Inactive
Code: WIL1404U79
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
Droxidopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-0721
Application NumberANDA213661
Product Classification
M
Marketing Category
C73584
G
Generic Name
Droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2019
FDA Product Classification
INGREDIENTS (11)
DroxidopaActive
Quantity: 200 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
gelatin type b bovine (230 bloom)Inactive
Code: WIL1404U79
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Droxidopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-0720
Application NumberANDA213661
Product Classification
M
Marketing Category
C73584
G
Generic Name
Droxidopa
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2019
FDA Product Classification
INGREDIENTS (13)
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
DroxidopaActive
Quantity: 100 mg in 1 1
Code: J7A92W69L7
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
gelatin type b bovine (230 bloom)Inactive
Code: WIL1404U79
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT