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Medicine

Droxidopa 100 mg capsule

Droxidopa · Oral
Available on requestPrescription onlyUS FDAGeneric name

Droxidopa 100 mg capsule is a generic prescription medicine for oral use, made by 12 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Droxidopa capsules should be stored at 20°C to 25°C (68°F to 77°F), excursions…

Key facts

Active ingredient (INN)
Droxidopa
Brand
Sold under the generic name
Strength
100 mg
Dosage form
Capsule
Route
Oral
Packs
90 capsules, 500 capsules, 1000 capsules and 13 more
Manufacturers
Ascend LaboratoriesIndiaNovadoz PharmaceuticalsIndiaZydus LifesciencesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaScieGen PharmaceuticalsBionpharmaCivicaScriptGolden State Medical SupplyMajor Pharmaceuticals12 labelers on the register
Origin register
US FDA, United States
Storage
Droxidopa capsules should be stored at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
C01CA27 Droxidopa
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
18 February 2021
Identifiers
RxCUI 1490026, 1490034, 1490038DailyMed set ID aa3ce55a-1ea9-4b50-b682-6f25398bcc29, 381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d, 049f997b-1649-467e-bbb9-bdb991b0bc6e +10NDC 70710-1389, 72205-072, 70436-140 +10Application ANDA211818, ANDA211741, ANDA215265 +6

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
90 capsule in 1 bottle70710-1389-9Zydus LifesciencesIndia19 February 2021
90 capsule in 1 bottle70771-1609-9Zydus LifesciencesIndia19 February 2021
500 capsule in 1 bottle67877-704-05Ascend LaboratoriesIndia19 February 2021
90 capsule in 1 bottle67877-704-90Ascend LaboratoriesIndia19 February 2021
90 capsule in 1 bottle59651-375-90Aurobindo PharmaIndia18 February 2021
90 capsule in 1 bottle31722-014-90Camber PharmaceuticalsIndia9 August 2021
500 capsule in 1 bottle72205-072-05Novadoz PharmaceuticalsIndia19 February 2021
90 capsule in 1 bottle72205-072-90Novadoz PharmaceuticalsIndia19 February 2021
90 capsule in 1 bottle, plastic69452-256-19Bionpharma1 October 2021
90 capsule in 1 bottle82249-551-90CivicaScript3 March 2025
1000 capsule in 1 bottle50228-429-10ScieGen Pharmaceuticals18 February 2021
30 capsule in 1 bottle50228-429-30ScieGen Pharmaceuticals18 February 2021
90 capsule in 1 bottle50228-429-90ScieGen Pharmaceuticals18 February 2021
90 capsule in 1 bottle70436-140-06Slate Run Pharmaceuticals10 November 2021
90 capsule in 1 bottle51407-765-90Golden State Medical Supply18 April 2023
90 capsule in 1 bottle0904-7392-89Major Pharmaceuticals28 December 2023

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 18 February 2014Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Droxidopa 100 mg capsule.

Compare 1

Other strengths and forms of Droxidopa

Clinical summary

Droxidopa is a prescription medicine indicated for the treatment of orthostatic dizziness, among other approved uses. It is available as capsules for oral use. MedsAcross supplies Droxidopa for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Droxidopa

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Droxidopa 100 mg capsule for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.