Droxidopa

Basic Information

Product Name

Droxidopa

FDA Product Code

0832-0721

Regulatory Information

NDC Product Code

0832-0721

Application Number

ANDA213661

Marketing Category

C73584

Effective Date

November 7, 2019

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

Droxidopa

Quantity: 200 mg in 1 1

Code: J7A92W69L7

Class Code: ACTIB

mannitol

Code: 3OWL53L36A

Class Code: IACT

starch, corn

Code: O8232NY3SJ

Class Code: IACT

magnesium stearate

Code: 70097M6I30

Class Code: IACT

gelatin type b bovine (230 bloom)

Code: WIL1404U79

Class Code: IACT

ferrosoferric oxide

Code: XM0M87F357

Class Code: IACT

water

Code: 059QF0KO0R

Class Code: IACT

ammonia

Code: 5138Q19F1X

Class Code: IACT

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

shellac

Code: 46N107B71O

Class Code: IACT

propylene glycol

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

Code: J7A92W69L7

Droxidopa

Basic Information

Regulatory Information

Company Information

Active Ingredients

mannitol

starch, corn

magnesium stearate

gelatin type b bovine (230 bloom)

ferrosoferric oxide

water

ammonia

titanium dioxide

shellac

propylene glycol

Active Moieties

Droxidopa