Medicine
Armodafinil 50 mg tablet
Armodafinil 50 mg tablet is a generic prescription medicine for oral use, made by 6 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Armodafinil
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 30 tablets, 60 tablets and 6 more
- Manufacturers
- Aurobindo PharmaIndiaNatco PharmaIndiaDirect_RxMylan PharmaceuticalsSandozTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- ATC code
- N06BA13 Armodafinil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 2016
- Identifiers
- RxCUI 724859, 724861, 724863 +1DailyMed set ID de0799f7-7644-4057-a7da-75436f978c61, de2f0921-e791-426c-9192-2b7162e2158c, facd329b-1925-61df-e053-6294a90ab738 +3NDC 0378-3431, 69339-177, 72189-464 +3Application ANDA200043, ANDA202768, ANDA206069 +1
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 tablet in 1 bottle | 65862-805-05 | Aurobindo PharmaIndia | 6 March 2018 |
| 30 tablet in 1 bottle | 65862-805-30 | Aurobindo PharmaIndia | 6 March 2018 |
| 60 tablet in 1 bottle | 65862-805-60 | Aurobindo PharmaIndia | 6 March 2018 |
| 30 tablet in 1 bottle | 69339-177-03 | Natco PharmaIndia | 23 March 2023 |
| 1000 tablet in 1 bottle | 69339-177-10 | Natco PharmaIndia | 23 March 2023 |
| 30 tablet in 1 bottle, plastic | 0378-3431-93 | Mylan Pharmaceuticals | 1 June 2016 |
| 30 tablet in 1 bottle | 0781-8029-31 | Sandoz | 1 December 2016 |
| 30 tablet in 1 bottle | 0093-3090-56 | Teva Pharmaceuticals | 29 November 2016 |
| 30 tablet in 1 bottle | 72189-464-30 | Direct_Rx | 3 May 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 15 June 2007 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 Armodafinil 50 mg tablet.
Other strengths and forms of Armodafinil
Clinical summary
Armodafinil is a prescription medicine indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). It is available as tablets for oral use. MedsAcross supplies Armodafinil 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 ArmodafinilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nuvigil prescribing information (Apotex) · U.S. National Library of Medicine, DailyMed
Need Armodafinil 50 mg tablet 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.