Medicine
Carbidopa, Entacapone and Levodopa 31.25 mg/200 mg/125 mg tablet
Carbidopa, Entacapone and Levodopa 31.25 mg/200 mg/125 mg tablet is a generic prescription medicine for oral use, made by 4 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F)…
Key facts
- Active ingredient (INN)
- Carbidopa, Entacapone and Levodopa
- Brand
- Sold under the generic name
- Strength
- 31.25 mg/200 mg/125 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 10 blister pack and 5 more
- Manufacturers
- Alembic PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaRising Pharma HoldingsSandoz
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) Dispense in tight container (USP).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N04BA03 Carbidopa, Entacapone and Levodopa
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 June 2014
- Identifiers
- RxCUI 403850, 403851, 403852 +3DailyMed set ID 9ff83838-b7d0-4eec-98f2-fcc85789a189, 9d4e886e-edec-471d-b619-bf4828a6b7ce, 2f8e82d7-6baf-456a-b8c3-4fda6e317902 +2NDC 46708-798, 62332-798, 16571-692 +2Application ANDA218535, ANDA213212, ANDA214495 +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 |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 46708-798-31 | Alembic PharmaceuticalsIndia | 12 February 2026 |
| 1000 tablet, film coated in 1 bottle | 46708-798-91 | Alembic PharmaceuticalsIndia | 12 February 2026 |
| 100 tablet, film coated in 1 bottle | 62332-798-31 | Alembic PharmaceuticalsIndia | 12 February 2026 |
| 1000 tablet, film coated in 1 bottle | 62332-798-91 | Alembic PharmaceuticalsIndia | 12 February 2026 |
| 100 tablet, film coated in 1 bottle | 33342-494-11 | Macleods PharmaceuticalsIndia | 15 April 2025 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-494-12 | Macleods PharmaceuticalsIndia | 15 April 2025 |
| 100 tablet, film coated in 1 bottle | 16571-692-01 | Rising Pharma Holdings | 5 August 2021 |
| 100 tablet, film coated in 1 bottle | 0781-5641-01 | Sandoz | 18 June 2014 |
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.
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
Other strengths and forms of Carbidopa, Entacapone and Levodopa
Clinical summary
Carbidopa, Entacapone and Levodopa is a fixed-dose combination of an aromatic amino acid and a catechol-O-methyltransferase inhibitor indicated for the treatment of Parkinson's disease, among other approved uses. MedsAcross supplies Carbidopa, Entacapone and Levodopa 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 Carbidopa, Entacapone and LevodopaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Carbidopa, Levodopa, and Entacapone prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
- Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz): European public assessment report (EPAR) · European Medicines Agency
- Levodopa/Carbidopa/Entacapone Orion: European public assessment report (EPAR) · European Medicines Agency
Need Carbidopa, Entacapone and Levodopa 31.25 mg/200 mg/125 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.