droxidopa

FDA Drug Profile — droxidopa, Droxidopa, Northera

droxidopa is listed in the FDA National Drug Code directory with 15 NDC codes, marketed under brand names including droxidopa, Droxidopa, Northera. Available dosage form: capsule.

Drug Details

Generic Name
droxidopa
Brand Names
droxidopa, Droxidopa, Northera
Application Number
ANDA215265
Sponsor
Slate Run Pharmaceuticals, LLC
NDC Codes
15
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
DROXIDOPA

Indications and Usage

1 INDICATIONS AND USAGE Droxidopa capsule is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of Droxidopa capsule should be assessed periodically. Droxidopa capsule is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of Droxidoa capsule should be assessed periodically ( 1 ).