Home › NDC Lookup › Ingredients › Droxidopa › 59651-0376-90
Droxidopa 200 mg Capsule, 90-count — NDC 59651-0376-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Droxidopa 200 mg Capsule, 90-count — NDC 59651-376-90 (Billing 59651-0376-90)

by Aurobindo Pharma Limited · 90 CAPSULE in 1 BOTTLE

This is a package of 90 capsules of Droxidopa 200 mg Capsule from Aurobindo Pharma Limited, marketed since Feb 2021 and currently FDA-listed; retail pharmacies pay about $2.13 per capsule (NADAC). It is this product's only package size.

NDC 59651-0376-90
🏷️ FDA NDC (as labeled) 59651-376-90 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 59651-376-90 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59651 labeler · 376 product · 90 package
Package marketed since
Feb 18, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
90 EA per package
Barcode (UPC-A, from the NDC)
3 5965137690 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59651-376-90
Product NDC 59651-376
11-digit billing NDC 59651037690
NCPDP billing unit EA — each (per item)
RxCUI 1490026, 1490034, 1490038
UNII J7A92W69L7
Application # ANDA214387
SPL Set ID ff263c9a-3db2-45ac-9ba6-8fca47199604
Physiologic effect Increased Blood Pressure
Chemical class Catecholamines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-02-18
Route ORAL
Dosage form CAPSULE
Substance DROXIDOPA
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 38700030000140
GPI class Droxidopa
GCN Seq No 072024
GCN 36089
HICL code 040936
Ingredient (HICL) Droxidopa
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5H
Therapeutic class — specific (HIC3) Adrenergic Vasopressor Agents
AHFS code 12:12.12.00
AHFS class Alpha- And Beta-Adrenergic Agonists
FDB label name DROXIDOPA 200 MG CAPSULE
FDB brand name Droxidopa
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 072024
  • GCN: 36089
  • GPI-14 (Medi-Span): 38700030000140
  • HICL (First Databank): 040936
  • AHFS class code: 12:12.12.00
  • RxCUI (RxNorm): 1490026
Why two NDCs? The FDA registers this code as 59651-376-90 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59651-0376-90. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Adrenergic and dopaminergic agents class.

Drug family (ATC) Adrenergic and dopaminergic agents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DROXIDOPA 200 MG CAPSULE Ingredient Droxidopa
📗 Our plain-language guide HelloPharmacist
  • It's designed to reduce the dizziness, lightheadedness, and near-blackouts you get when you stand up — a problem called neurogenic orthostatic hypotension, or nOH. Your nervous sys...
  • What exactly is droxidopa supposed to do for me?
  • You take it three times a day — morning, midday, and in the late afternoon. The critical rule is that your last dose has to be at least 3 hours before you go to bed, because it can...
  • When during the day should I take my doses, and does food matter?
📖 Read our full Droxidopa guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $2.128 $191.56 / 90 capsules
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $4.06 $365.24 / 90 capsules
NADAC price history (per ea) — tap or hover for the price & month
Feb 2023 $2.128 $2.128
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
59651-0376-90 You're viewing this Main listing 90 CAPSULE in 1 BOTTLE 2021-02-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Droxidopa 200 mg 00904-7393-89 MAJOR 90 capsules $0.901 AB Availability likely save 58%
Droxidopa 200 mg 31722-0015-90 Camber 90 capsules $0.901 AB Availability likely save 58%
Droxidopa 200 mg 70710-1390-09 Zydus 90 capsules $0.901 AB Availability likely save 58%
Droxidopa 200 mg 82249-0552-90 CivicaScript 90 capsules $0.901 AB Availability likely save 58%
droxidopa 200 ug 63304-0104-90 Sun 90 capsules $1.673 AB FDA listed save 21%
Droxidopa 200 mgthis 59651-0376-90 Aurobindo 90 capsules $2.128 AB FDA listed —
droxidopa 200 mg 70436-0141-06 Slate 90 capsules $2.128 AB FDA listed —
Droxidopa 200 mg 50228-0430-10 ScieGen 1000 capsules — AB FDA listed —
Droxidopa 200 mg 51407-0766-90 Golden 90 capsules — AB FDA listed —
Northera 200 mg 67386-0821-19 Lundbeck 90 capsules — AB FDA listed —
Droxidopa 200 mg 67877-0705-05 Ascend 500 capsules — AB FDA listed —
Droxidopa 200 mg 69452-0257-19 Bionpharma 90 capsules — AB FDA listed —
Droxidopa 200 mg 70771-1610-09 Zydus 90 capsules — AB FDA listed —
Droxidopa 200 mg 72205-0073-05 Novadoz 500 capsules — AB FDA listed —
Droxidopa 200 mg 68180-0988-02 Lupin 500 capsules — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Feb 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Blue / Yellow / Green
ShapeCapsule
ImprintDROH;300
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA214387 (ANDA)
Labeler code59651
First marketedFeb 2021
Product typeHuman Prescription Drug
Portfolio1,456 products on file

More NDCs from Aurobindo Pharma Limited labeler code 59651

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 136 words ▾

WARNING: SUPINE HYPERTENSION Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measured in this position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue droxidopa [see Warnings and Precautions (5.1) ] .

WARNING: SUPINE HYPERTENSION See full prescribing information for complete boxed warning. Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measured in this position.

If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue droxidopa [see Warnings and Precautions (5.1) ] .

🎯 Indications and Usage 151 words ▾

1 INDICATIONS AND USAGE Droxidopa capsules are 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 capsules should be assessed periodically.

Droxidopa capsules are 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 capsules should be assessed periodically ( 1 ).

⏱️ Dosage and Administration 207 words ▾

2 DOSAGE AND ADMINISTRATION Starting dose is 100 mg three times during the day ( 2.1 ) Titrate by 100 mg three times daily, up to a maximum dose of 600 mg three times daily ( 2.1 ) Take consistently with or without food ( 2.1 ) To reduce the potential for supine hypertension, elevate the head of the bed and give the last dose at least 3 hours prior to bedtime ( 2.1 ) Take droxidopa capsule whole ( 2.1 )

2.1Dosing Information The recommended starting dose of droxidopa capsules is 100 mg, taken orally three times daily: upon arising in the morning, at midday, and in the late afternoon at least 3 hours prior to bedtime (to reduce the potential for supine hypertension during sleep). Administer droxidopa capsules consistently, either with food or without food. Take droxidopa capsule whole.

Titrate to symptomatic response, in increments of 100 mg three times daily every 24 to 48 hours up to a maximum dose of 600 mg three times daily (i.e., a maximum total daily dose of 1,800 mg). Monitor supine blood pressure prior to initiating droxidopa capsules and after increasing the dose. Patients who miss a dose of droxidopa capsules should take their next scheduled dose.

💊 Dosage Forms and Strengths 122 words ▾

3 DOSAGE FORMS AND STRENGTHS Droxidopa capsules are available in 100 mg, 200 mg, and 300 mg strengths as specified below. 100 mg: Light blue opaque cap and blue opaque body, hard gelatin capsule shell imprinted “DROH” on cap and “100” on the body filled with white to off white granules. 200 mg: Light yellow opaque cap and blue opaque body, hard gelatin capsule shell imprinted “DROH” on cap and “200” on the body filled with white to off white granules.

300 mg: Light green opaque cap and blue opaque body, hard gelatin capsule shell imprinted “DROH” on cap and “300” on the body filled with white to off white granules. 100 mg, 200 mg, and 300 mg capsules ( 3 )

⛔ Contraindications 38 words ▾

4 CONTRAINDICATIONS Droxidopa capsules are contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients [see Warnings and Precautions (5.4) ]. History of hypersensitivity to the drug or its ingredients ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Doxidopa may cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed ( 5.1 ) Hyperpyrexia and confusion ( 5.2 ) May exacerbate symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure ( 5.3 ) Allergic reactions ( 5.4 )

5.1Supine Hypertension Droxidopa therapy may cause or exacerbate supine hypertension in patients with nOH. Patients should be advised to elevate the head of the bed when resting or sleeping. Monitor blood pressure, both in the supine position and in the recommended head-elevated sleeping position.

Reduce or discontinue droxidopa if supine hypertension persists. If supine hypertension is not well-managed, droxidopa may increase the risk of cardiovascular events, particularly stroke.

5.2Hyperpyrexia and Confusion Postmarketing cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported with droxidopa use during postmarketing surveillance. Observe patients carefully when the dosage of droxidopa is changed or when concomitant levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia, muscle rigidity, involuntary movements, altered consciousness, and mental status changes.

The early diagnosis of this condition is important for the appropriate management of these patients.

5.3Ischemic Heart Disease, Arrhythmias, and Congestive Heart Failure Droxidopa may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure. Careful consideration should be given to this potential risk prior to initiating therapy in patients with these conditions.

5.4Allergic Reactions Hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, urticaria and rash have been reported in postmarketing experience. Some of these reactions resulted in emergency treatment. If a hypersensitivity reaction occurs, discontinue the drug and initiate appropriate therapy.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions with droxidopa are included in more detail in the Warnings and Precautions section of the label: Supine Hypertension [see Warnings and Precautions (5.1) ] Hyperpyrexia and Confusion [see Warnings and Precautions (5.2) ] May exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure [see Warnings and Precautions (5.3) ] The most common adverse reactions (>5% and ≥3% compared to placebo) are headache, dizziness, nausea, and hypertension ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety evaluation of droxidopa is based on two placebo-controlled studies 1 to 2 weeks in duration (Studies 301 and 302), one 8-week placebo-controlled study (Study 306), and two long-term, open-label extension studies (Studies 303 and 304).

In the placebo-controlled studies, a total of 485 patients with Parkinson's disease, multiple system atrophy, pure autonomic failure, dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy were randomized and treated, 245 with droxidopa and 240 with placebo [see Clinical Studies (14) ] . Placebo-Controlled Experience The most commonly observed adverse reactions (those occurring at an incidence of greater than 5% in the droxidopa group and with at least a 3% greater incidence in the droxidopa group than in the placebo group) in droxidopa-treated patients during the three placebo-controlled trials were headache, dizziness, nausea, and hypertension.

The most common adverse reactions leading to discontinuation from droxidopa were hypertension or increased blood pressure and nausea. Table 1. Most Common Adverse Reactions Occurring More Frequently in the Droxidopa Group Study 301 and Study 302 (1 to 2 Weeks Randomized Treatment) Study 306 (8 to 10 Weeks Randomized Treatment) Placebo (N=132) n (%) Droxidopa (N=131) n (%) Placebo (N=108) n (%) Droxidopa (N=114) n (%) Headache 4 (3.0) 8 (6.1) 8 (7.4) 15 (13.2) Dizziness 2 (1.5) 5 (3.8) 5 (4.6) 11 (9.6) Nausea 2 (1.5) 2 (1.5) 5 (4.6) 10 (8.8) Hypertension 0 2 (1.5) 1 (0.9) 8 (7.0) Note: n=number of patients.

Adverse reactions that were reported in greater than 5% of patients in the droxidopa group and with at least a 3% greater incidence in the droxidopa group than in the placebo group were from Study 306. Long-Term, Open-Label Trials with Droxidopa In the long-term, open-label extension studies, a total of 422 patients, mean age 65 years, were treated with droxidopa for a mean total exposure of approximately one year. The commonly reported adverse events were falls (24%), urinary tract infections (15%), headache (13%), syncope (13%), and dizziness (10%).

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of droxidopa. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders: Chest pain Eye Disorders: Blurred vision Gastrointestinal Disorders: Pancreatitis, abdominal pain, vomiting, diarrhea General Disorders and Administration Site Conditions: Fatigue Nervous System Disorders: Cerebrovascular accident Psychiatric Disorders: Psychosis, hallucination, delirium, agitation, memory disorder

🔄 Drug Interactions 114 words ▾

7 DRUG INTERACTIONS Use of DOPA decarboxylase inhibitors may require dose adjustments for droxidopa ( 7.2 )

7.1Drugs that Increase Blood Pressure Administering droxidopa in combination with other agents that increase blood pressure (e.g., norepinephrine, ephedrine, midodrine, and triptans) would be expected to increase the risk for supine hypertension.

7.2Parkinson’s Medications Dopa-decarboxylase inhibitors may require dose adjustments for droxidopa.

7.3Non-selective MAO Inhibitors The concomitant use of selective MAO-B inhibitors, such as rasagiline or selegiline, was permitted in the droxidopa clinical trials. However, based on mechanism of action, the use of non-selective MAO inhibitors and linezolid should be avoided as there is a potential for increased blood pressure when taken with droxidopa.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended ( 8.2 ) Patients with Renal Impairment: Dosing recommendations cannot be provided for patients with GFR less than 30 mL/min ( 8.6 )

8.1Pregnancy Risk Summary There are no available data on use of droxidopa in pregnant women and risk of major birth defects or miscarriage. Droxidopa did not produce significant reproductive toxicity in pregnant female rats or rabbits or in their fetuses. However, when pregnant female rats were dosed during days 7 to 17 of gestation (the period of fetal organogenesis) with doses of droxidopa corresponding to 0.3, 1 and 3 times the maximum recommended daily dose of 1,800 mg in a 60 kg patient, based on body surface area, and when their male and female offspring (who were exposed only during fetal life) were subsequently bred, the female offspring exhibited a dose-dependent reduction in the number of live fetuses across all three doses and an increased number of embryonic/fetal deaths at the two higher doses ( see Data ).

The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data During a multigenerational reproductive toxicity study in rats, pregnant females were dosed during days 7 to 17 of gestation (the period of fetal organogenesis) with doses of droxidopa corresponding to 0.3, 1 and 3 times the maximum recommended daily dose of 1,800 mg in a 60 kg patient.

Reduced weight gain, renal lesions, and a small number of deaths were observed in females treated with the two higher doses. When their male and female offspring (who were exposed to droxidopa only during fetal life) were subsequently bred, the female offspring exhibited a dose-dependent reduction in the number of live fetuses across all three doses and an increased number of embryonic/fetal deaths at the two higher doses.

8.2Lactation Risk Summary There is no information regarding the presence of droxidopa or its active metabolite(s) in human milk, the effects of droxidopa on the breastfed child, nor the effects of droxidopa on milk production/excretion. Droxidopa is present in rat milk with peak concentrations seen 4 hours after oral drug administration and drug excretion into milk still occurring 48 hours after administration ( see Data ). However, due to species-specific differences in lactation physiology, animal lactation data typically do not reliably predict levels in humans.

Because of the potential for serious adverse reactions, including reduced weight gain in breastfed infants, advise a woman not to breastfeed during treatment with droxidopa. Data Animal Data In rats, oral administration of droxidopa resulted in excretion into breast milk with peak concentrations seen 4 hours after administration, and excretion still occurring 48 hours after administration. When the drug was administered to nursing dams during the period of lactation at a dose corresponding to 3 times the maximum recommended daily dose of 1,800 mg in a 60 kg patient when based on body surface area, reduced weight gain and reduced survival were observed in the offspring.

Despite the observed decreased weight gain, physical development was normal (with respect to timing and organ morphology).

8.4Pediatric Use The safety and effectiveness of droxidopa in pediatric patients have not been established.

8.5Geriatric Use A total of 197 patients with symptomatic nOH aged 75 years or above were included in the droxidopa clinical program. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.6 Renal Impairment D…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no available data on use of droxidopa in pregnant women and risk of major birth defects or miscarriage. Droxidopa did not produce significant reproductive toxicity in pregnant female rats or rabbits or in their fetuses. However, when pregnant female rats were dosed during days 7 to 17 of gestation (the period of fetal organogenesis) with doses of droxidopa corresponding to 0.3, 1 and 3 times the maximum recommended daily dose of 1,800 mg in a 60 kg patient, based on body surface area, and when their male and female offspring (who were exposed only during fetal life) were subsequently bred, the female offspring exhibited a dose-dependent reduction in the number of live fetuses across all three doses and an increased number of embryonic/fetal deaths at the two higher doses ( see Data ).

The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data During a multigenerational reproductive toxicity study in rats, pregnant females were dosed during days 7 to 17 of gestation (the period of fetal organogenesis) with doses of droxidopa corresponding to 0.3, 1 and 3 times the maximum recommended daily dose of 1,800 mg in a 60 kg patient.

Reduced weight gain, renal lesions, and a small number of deaths were observed in females treated with the two higher doses. When their male and female offspring (who were exposed to droxidopa only during fetal life) were subsequently bred, the female offspring exhibited a dose-dependent reduction in the number of live fetuses across all three doses and an increased number of embryonic/fetal deaths at the two higher doses.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of droxidopa in pediatric patients have not been established.

🧓 Geriatric Use 66 words ▾

8.5Geriatric Use A total of 197 patients with symptomatic nOH aged 75 years or above were included in the droxidopa clinical program. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 103 words ▾

10 OVERDOSAGE

10.1Symptoms There have been cases of overdose reported during postmarketing surveillance. A patient ingested 7,700 mg of droxidopa and experienced a hypertensive crisis that resolved promptly with treatment. Another patient treated with a total daily dose of 2,700 mg of droxidopa experienced hypertension and an intracranial hemorrhage.

10.2Treatment There is no known antidote for droxidopa overdosage. In case of an overdose that may result in an excessively high blood pressure, discontinue droxidopa and treat with appropriate symptomatic and supportive therapy. Counsel patients to remain in a standing or seated position until their blood pressure drops below an acceptable limit.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The exact mechanism of action of droxidopa in the treatment of neurogenic orthostatic hypotension is unknown. Droxidopa is a synthetic amino acid analog that is directly metabolized to norepinephrine by dopa-decarboxylase, which is extensively distributed throughout the body. Droxidopa is believed to exert its pharmacological effects through norepinephrine and not through the parent molecule or other metabolites.

Norepinephrine increases blood pressure by inducing peripheral arterial and venous vasoconstriction. Droxidopa in humans induces small and transient rises in plasma norepinephrine.

12.2Pharmacodynamics Peak droxidopa plasma concentrations are associated with increases in systolic and diastolic blood pressures. Droxidopa has no clinically significant effect on standing or supine heart rates in patients with autonomic failure. Cardiac Electrophysiology No prolongation of the QTc interval was observed with droxidopa at single oral doses up to 2,000 mg, as shown in a dedicated thorough QT study.

12.3Pharmacokinetics Absorption Peak plasma concentrations (C max ) of droxidopa were reached by 1 to 4 hours post-dose (mean of approximately 2 hours) in healthy volunteers. High-fat meals have a moderate impact on droxidopa exposure with C max and area under the plasma concentration-time curve (AUC) decreasing by 35% and 20%, respectively. The C max was delayed by approximately 2 hours with a high-fat meal.

Distribution Pre-clinical studies suggest that droxidopa can cross the blood-brain barrier. Droxidopa exhibits plasma protein binding of 75% at 100 ng/mL and 26% at 10,000 ng/mL. The estimated apparent volume of distribution of droxidopa is about 200 L in humans.

Elimination The total clearance of droxidopa after oral administration (CL/F) was approximately 400 mL/hr following administration of a single 300 mg dose. Metabolism The metabolism of droxidopa is mediated by catecholamine pathway and not through the cytochrome P450 system. Droxidopa is initially converted to methoxylated dihydroxyphenylserine (3-OM-DOPS), a major metabolite, by catechol-O-methyltransferase (COMT), to norepinephrine by DOPA decarboxylase (DDC), or to protocatechualdehyde by DOPS aldolase.

After oral dosing in humans, plasma norepinephrine levels peak within 3 to 4 hours but are generally very low (less than 1 ng/mL) and variable with no consistent relationship with dose. The contribution of the metabolites of droxidopa other than norepinephrine to its pharmacological effects is not well understood. Excretion The mean elimination half-life of droxidopa is approximately 2.5 hours in humans.

The major route of elimination of droxidopa and its metabolites is via the kidneys in both animals and in humans. Studies in animals with radiolabeled drug showed that ~75% of the administered radioactivity was excreted in urine within 24 hours of oral dosing. Specific Populations There are no clinically relevant effects of age, body mass index, or sex on the pharmacokinetics of droxidopa.

A population pharmacokinetic analysis suggests that hepatic function, assessed by aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, and total bilirubin, did not influence the exposure to droxidopa. The controlled clinical trials included patients with mild to moderate renal impairment. No dose adjustments are required in patients with mild to moderate renal impairment.

Drug Interaction Studies No dedicated drug-drug interaction studies were performed for droxidopa. Patients in the Phase 3 trials with droxidopa received concomitant levodopa/carbidopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors and other medications used to treat Parkinson’s disease. Carbidopa, a peripheral dopa-decarboxylase inhibitor, could prevent the conversion of droxidopa to norepinephrine outside of the central nervous system (CNS).

Patients taking droxidopa with L-DOPA/dopa-decarboxylase inhibitor combination…

🧬 Mechanism of Action 83 words ▾

12.1Mechanism of Action The exact mechanism of action of droxidopa in the treatment of neurogenic orthostatic hypotension is unknown. Droxidopa is a synthetic amino acid analog that is directly metabolized to norepinephrine by dopa-decarboxylase, which is extensively distributed throughout the body. Droxidopa is believed to exert its pharmacological effects through norepinephrine and not through the parent molecule or other metabolites.

Norepinephrine increases blood pressure by inducing peripheral arterial and venous vasoconstriction. Droxidopa in humans induces small and transient rises in plasma norepinephrine.

📦 How Supplied / Storage and Handling 164 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Droxidopa capsules are supplied in the following dosage strengths: Droxidopa Capsules, 100 mg are light blue opaque cap and blue opaque body, hard gelatin capsule shell size “3” imprinted “DROH” on cap and “100” on the body filled with white to off white granules. Bottles of 90 NDC 59651-375-90 Droxidopa Capsules, 200 mg are light yellow opaque cap and blue opaque body, hard gelatin capsule shell size “2” imprinted “DROH” on cap and “200” on the body filled with white to off white granules. Bottles of 90 NDC 59651-376-90 Droxidopa Capsules, 300 mg are light green opaque cap and blue opaque body, hard gelatin capsule shell size “1” imprinted “DROH” on cap and “300” on the body filled with white to off white granules.

Bottles of 90 NDC 59651-377-90

16.2Storage and Handling Droxidopa capsules should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

📋 Description 173 words ▾

11 DESCRIPTION Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the following structural formula: Droxidopa is white to off-white powder.

It is slightly soluble in water and practically insoluble in ethanol. It has a molecular weight of 213.19 and a molecular formula of C 9 H 11 NO 5 . Droxidopa capsules also contain the following inactive ingredients: corn starch, magnesium stearate and mannitol.

The capsule shell is printed with black ink. The black ink contains black iron oxide, potassium hydroxide and shellac. The capsule shell contains the following inactive ingredients: 100 mg-FD&C Blue 1, gelatin, iron oxide black, iron oxide red and titanium dioxide; 200 mg-FD&C Blue 1, gelatin, iron oxide black, iron oxide red, iron oxide yellow and titanium dioxide; 300 mg – D&C Yellow 10, FD&C Blue 1, gelatin, iron oxide black, iron oxide red and titanium dioxide.

Droxidopa capsules differ in size and color by strength [see Dosage Forms and Strengths (3) ]. Chemical structer

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Elevations in Blood Pressure Counsel patients that droxidopa causes elevations in blood pressure and increases the risk of supine hypertension, which could lead to strokes, heart attacks, and death. Instruct patients to rest and sleep in an upper-body elevated position and monitor blood pressure. Instruct patients how to manage observed blood pressure elevations.

To reduce the risk of supine hypertension, in addition to raising the upper body, the late afternoon dose of droxidopa should be taken at least three hours before bedtime [see Warnings and Precautions (5.1) ] . Concomitant Treatments Counsel patients about the concomitant use of drugs to treat other conditions that may have an additive effect with droxidopa [see Drug Interactions (7) ]. Allergic Reactions Counsel patients to discontinue droxidopa and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction such as anaphylaxis, angioedema, bronchospasm, urticaria or rash occur [see Warnings and Precautions (5.4) ].

Lactation Advise women not to breastfeed during treatment with droxidopa [see Use in Specific Populations (8.2) ]. Food Patients should take droxidopa the same way each time, either with food or without food [see Dosage and Administration (2.1) ] . Missed Dose If a dose is missed, patients should take the next dose at the regularly scheduled time and should not double the dose.

Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Issued: May 2020

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Droxidopa — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Droxidopa. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$14.96M
Claims incl. refills
14.7K
Beneficiaries
6.4K
Spend / beneficiary
$2,326.03
Spend / claim
$1,018.02
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 59651-0375-90 · Aurobindo 59651-0377-90 · Aurobindo →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.