Medicine
Carbidopa and Levodopa 25 mg/100 mg extended-release tablet
Carbidopa and Levodopa 25 mg/100 mg extended-release tablet 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
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). Store…
Key facts
- Active ingredient (INN)
- Carbidopa and Levodopa
- Brand
- Sold under the generic name
- Strength
- 25 mg/100 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 1000 tablets and 24 more
- Manufacturers
- Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaAccord HealthcareIndiaAdvagen PharmaAmneal Pharmaceuticals NYScieGen PharmaceuticalsBryant Ranch PrepackMylan InstitutionalMylan PharmaceuticalsRadha Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Store in a tightly closed container, protected from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N04BA02 Carbidopa and Levodopa
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 April 2000
- Identifiers
- RxCUI 308988, 308989DailyMed set ID 5b6519ff-d1af-402b-83eb-b4fce6743a18, 043e58c6-092d-4637-90f1-9d36af143a24, 0eb24333-3c11-41dd-888d-3a30d3c9d188 +10NDC 72888-155, 72162-2194, 60219-2033 +10Application ANDA217482, ANDA214091, ANDA076521 +4
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 |
|---|---|---|---|
| 30 tablet, extended release in 1 bottle | 46708-332-30 | Alembic PharmaceuticalsIndia | 6 June 2019 |
| 100 tablet, extended release in 1 bottle | 46708-332-31 | Alembic PharmaceuticalsIndia | 6 June 2019 |
| 1000 tablet, extended release in 1 bottle | 46708-332-91 | Alembic PharmaceuticalsIndia | 6 June 2019 |
| 30 tablet, extended release in 1 bottle | 62332-332-30 | Alembic PharmaceuticalsIndia | 6 June 2019 |
| 100 tablet, extended release in 1 bottle | 62332-332-31 | Alembic PharmaceuticalsIndia | 6 June 2019 |
| 1000 tablet, extended release in 1 bottle | 62332-332-91 | Alembic PharmaceuticalsIndia | 6 June 2019 |
| 100 tablet, extended release in 1 bottle | 16729-078-01 | Accord HealthcareIndia | 13 June 2013 |
| 1000 tablet, extended release in 1 bottle | 16729-078-17 | Accord HealthcareIndia | 31 October 2013 |
| 100 tablet, extended release in 1 bottle | 62756-461-08 | Sun Pharmaceutical IndustriesIndia | 23 August 2007 |
| 1000 tablet, extended release in 1 bottle | 62756-461-18 | Sun Pharmaceutical IndustriesIndia | 23 August 2007 |
| 30 tablet, extended release in 1 bottle | 62756-461-83 | Sun Pharmaceutical IndustriesIndia | 23 August 2007 |
| 1000 tablet, extended release in 1 bottle | 72888-155-00 | Advagen Pharma | 4 June 2024 |
| 100 tablet, extended release in 1 bottle | 72888-155-01 | Advagen Pharma | 4 June 2024 |
| 500 tablet, extended release in 1 bottle | 72888-155-05 | Advagen Pharma | 4 June 2024 |
| 30 tablet, extended release in 1 bottle | 72888-155-30 | Advagen Pharma | 4 June 2024 |
| 100 tablet, extended release in 1 bottle | 60219-2033-1 | Amneal Pharmaceuticals NY | 21 December 2022 |
| 30 tablet, extended release in 1 bottle | 60219-2033-3 | Amneal Pharmaceuticals NY | 21 December 2022 |
| 500 tablet, extended release in 1 bottle | 60219-2033-5 | Amneal Pharmaceuticals NY | 21 December 2022 |
| 100 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack | 51079-978-20 | Mylan Institutional | 1 February 2002 |
| 100 tablet, extended release in 1 bottle, plastic | 0378-0088-01 | Mylan Pharmaceuticals | 26 April 2000 |
| 100 tablet, extended release in 1 bottle | 77771-460-01 | Radha Pharmaceuticals | 25 April 2025 |
| 100 tablet, extended release in 1 bottle | 50228-460-01 | ScieGen Pharmaceuticals | 5 October 2021 |
| 1000 tablet, extended release in 1 bottle | 50228-460-10 | ScieGen Pharmaceuticals | 5 October 2021 |
| 30 tablet, extended release in 1 bottle | 50228-460-30 | ScieGen Pharmaceuticals | 5 October 2021 |
| 100 tablet, extended release in 1 bottle | 72162-2194-1 | Bryant Ranch Prepack | 15 December 2023 |
| 100 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack | 48433-015-20 | Safecor Health | 13 March 2026 |
| 30 tablet, extended release in 1 blister pack | 0615-8460-39 | Vangard Labs | 28 March 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.
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 and Levodopa
Clinical summary
Carbidopa and Levodopa is a fixed-dose combination medicine indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. MedsAcross supplies Carbidopa 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 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
- SINEMET prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
- Hopledo: European public assessment report (EPAR) · European Medicines Agency
- Onerji: European public assessment report (EPAR) · European Medicines Agency
Need Carbidopa and Levodopa 25 mg/100 mg extended-release 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.