Medicine
Cevimeline 30 mg capsule
Cevimeline 30 mg capsule is a generic prescription medicine for oral use, made by 15 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), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Cevimeline
- Brand
- Sold under the generic name
- Strength
- 30 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 30 capsules and 40 more
- Manufacturers
- Novel LaboratoriesIndiaAurobindo PharmaIndiaMacleods PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaBryant Ranch PrepackAsclemedAdvagen PharmaHikma Pharmaceuticals15 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07AX03 Cevimeline
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 July 2013
- Identifiers
- RxCUI 309140DailyMed set ID 75ae16d6-8822-4581-b747-ae894a45cdea, d7432a48-1142-431e-997f-8419dc724824, d08d8aa5-76a4-417a-a308-7d195865522f +18NDC 71335-2326, 40032-999, 59651-422 +18Application ANDA216682, ANDA204746, ANDA215056 +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
A sample of 40 packs from 15 labelers. The register lists 43 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 59651-422-01 | Aurobindo PharmaIndia | 18 April 2023 |
| 500 capsule in 1 bottle | 59651-422-05 | Aurobindo PharmaIndia | 18 April 2023 |
| 100 capsule in 1 bottle | 33342-216-11 | Macleods PharmaceuticalsIndia | 20 October 2024 |
| 100 capsule in 1 bottle | 40032-999-01 | Novel LaboratoriesIndia | 30 December 2016 |
| 30 capsule in 1 bottle | 40032-999-03 | Novel LaboratoriesIndia | 30 December 2016 |
| 500 capsule in 1 bottle | 40032-999-05 | Novel LaboratoriesIndia | 30 December 2016 |
| 100 capsule in 1 bottle | 63304-479-01 | Sun Pharmaceutical IndustriesIndia | 10 March 2016 |
| 100 capsule in 1 bottle | 72578-208-01 | Viona PharmaceuticalsIndia | 15 April 2026 |
| 100 capsule in 1 bottle | 70771-1982-1 | Zydus LifesciencesIndia | 15 April 2026 |
| 100 capsule in 1 bottle | 0054-0334-25 | Hikma Pharmaceuticals | 8 July 2013 |
| 100 capsule in 1 bottle | 0054-0893-25 | Hikma Pharmaceuticals | 5 October 2026 |
| 1000 capsule in 1 bottle, plastic | 72888-118-00 | Advagen Pharma | 3 May 2023 |
| 100 capsule in 1 bottle, plastic | 72888-118-01 | Advagen Pharma | 3 May 2023 |
| 500 capsule in 1 bottle, plastic | 72888-118-05 | Advagen Pharma | 3 May 2023 |
| 30 capsule in 1 bottle, plastic | 72888-118-30 | Advagen Pharma | 3 May 2023 |
| 100 capsule in 1 bottle | 69452-316-20 | Bionpharma | 17 January 2024 |
| 100 capsule in 1 bottle, plastic | 0713-0937-01 | Cosette Pharmaceuticals | 3 January 2023 |
| 100 capsule in 1 bottle | 16571-657-10 | Rising Pharma Holdings | 17 June 2014 |
| 30 capsule in 1 bottle | 63629-9863-1 | Bryant Ranch Prepack | 30 November 2023 |
| 60 capsule in 1 bottle | 63629-9863-2 | Bryant Ranch Prepack | 5 September 2024 |
| 90 capsule in 1 bottle | 63629-9863-3 | Bryant Ranch Prepack | 5 September 2024 |
| 30 capsule in 1 bottle | 71335-2264-1 | Bryant Ranch Prepack | 27 October 2023 |
| 60 capsule in 1 bottle | 71335-2264-2 | Bryant Ranch Prepack | 27 October 2023 |
| 90 capsule in 1 bottle | 71335-2264-3 | Bryant Ranch Prepack | 27 October 2023 |
| 30 capsule in 1 bottle, plastic | 71335-2326-1 | Bryant Ranch Prepack | 8 January 2024 |
| 60 capsule in 1 bottle, plastic | 71335-2326-2 | Bryant Ranch Prepack | 8 January 2024 |
| 90 capsule in 1 bottle, plastic | 71335-2326-3 | Bryant Ranch Prepack | 8 January 2024 |
| 30 capsule in 1 bottle | 71335-3168-1 | Bryant Ranch Prepack | 4 August 2026 |
| 60 capsule in 1 bottle | 71335-3168-2 | Bryant Ranch Prepack | 4 August 2026 |
| 90 capsule in 1 bottle | 71335-3168-3 | Bryant Ranch Prepack | 4 August 2026 |
| 100 capsule in 1 bottle | 72162-2563-1 | Bryant Ranch Prepack | 4 November 2025 |
| 100 capsule in 1 bottle | 87063-180-01 | Asclemed | 18 May 2026 |
| 30 capsule in 1 bottle | 87063-180-30 | Asclemed | 18 May 2026 |
| 60 capsule in 1 bottle | 87063-180-60 | Asclemed | 18 May 2026 |
| 90 capsule in 1 bottle | 87063-180-90 | Asclemed | 18 May 2026 |
| 100 capsule in 1 bottle, plastic | 87063-324-01 | Asclemed | 2 October 2026 |
| 10 capsule in 1 bottle, plastic | 87063-324-10 | Asclemed | 2 October 2026 |
| 20 capsule in 1 bottle, plastic | 87063-324-20 | Asclemed | 2 October 2026 |
| 30 capsule in 1 bottle, plastic | 87063-324-30 | Asclemed | 2 October 2026 |
| 60 capsule in 1 bottle, plastic | 87063-324-60 | Asclemed | 2 October 2026 |
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 11 January 2000 | 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 Cevimeline 30 mg capsule.
Clinical summary
Cevimeline is a cholinergic receptor agonist indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome. It is available as capsules for oral use. MedsAcross supplies Cevimeline 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 CevimelineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- cevimeline hydrochloride prescribing information (Cosette Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Cevimeline 30 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.