Medicine
Carbamazepine 100 mg extended-release tablet
Carbamazepine 100 mg extended-release tablet is a generic prescription medicine for oral use, made by 19 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°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Carbamazepine
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 30 tablets and 40 more
- Manufacturers
- Zydus LifesciencesIndiaTorrent PharmaceuticalsIndiaAlembic PharmaceuticalsIndiaAscend LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaUmedica LaboratoriesIndiaAjanta PharmaIndiaJubilant Cadista PharmaceuticalsIndiaBostalNorthStar Rx19 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AF01 Carbamazepine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 March 2009
- Identifiers
- RxCUI 199378, 402505, 402506 +4DailyMed set ID b563e4a1-d7dd-4901-ad45-614f85687589, 2e3c4854-89a1-4e3f-88d4-e164829585fb, d10e5f83-56db-4bc9-8c51-150a2e3e20ea +19NDC 72603-886, 27241-231, 70771-1468 +19Application ANDA216594, ANDA216193, ANDA205571 +9
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 19 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 tablet, film coated, extended release in 1 bottle | 46708-420-31 | Alembic PharmaceuticalsIndia | 26 July 2025 |
| 1000 tablet, film coated, extended release in 1 bottle | 46708-420-91 | Alembic PharmaceuticalsIndia | 26 July 2025 |
| 100 tablet, film coated, extended release in 1 bottle | 62332-420-31 | Alembic PharmaceuticalsIndia | 26 July 2025 |
| 1000 tablet, film coated, extended release in 1 bottle | 62332-420-91 | Alembic PharmaceuticalsIndia | 26 July 2025 |
| 100 tablet, extended release in 1 bottle | 68382-555-01 | Zydus LifesciencesIndia | 12 March 2019 |
| 30 tablet, extended release in 1 bottle | 68382-555-06 | Zydus LifesciencesIndia | 12 March 2019 |
| 90 tablet, extended release in 1 bottle | 68382-555-16 | Zydus LifesciencesIndia | 12 March 2019 |
| 10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 68382-555-30 | Zydus LifesciencesIndia | 12 March 2019 |
| 100 tablet, extended release in 1 bottle | 70771-1468-1 | Zydus LifesciencesIndia | 12 March 2019 |
| 30 tablet, extended release in 1 bottle | 70771-1468-3 | Zydus LifesciencesIndia | 12 March 2019 |
| 10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 70771-1468-4 | Zydus LifesciencesIndia | 12 March 2019 |
| 90 tablet, extended release in 1 bottle | 70771-1468-9 | Zydus LifesciencesIndia | 12 March 2019 |
| 100 tablet, extended release in 1 bottle | 27241-231-01 | Ajanta PharmaIndia | 24 March 2023 |
| 100 tablet, extended release in 1 bottle | 67877-797-01 | Ascend LaboratoriesIndia | 1 November 2025 |
| 500 tablet, extended release in 1 bottle | 67877-797-05 | Ascend LaboratoriesIndia | 1 November 2025 |
| 30 tablet, extended release in 1 bottle | 67877-797-30 | Ascend LaboratoriesIndia | 1 November 2025 |
| 1 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 67877-797-33 | Ascend LaboratoriesIndia | 1 November 2025 |
| 100 tablet, extended release in 1 bottle | 59746-789-01 | Jubilant Cadista PharmaceuticalsIndia | 20 August 2022 |
| 100 tablet, extended release in 1 bottle | 51672-4123-1 | Sun Pharmaceutical IndustriesIndia | 31 March 2009 |
| 1000 tablet, extended release in 1 bottle | 51672-4123-3 | Sun Pharmaceutical IndustriesIndia | 31 March 2009 |
| 30 tablet, extended release in 1 bottle | 51672-4123-6 | Sun Pharmaceutical IndustriesIndia | 31 March 2009 |
| 100 tablet, extended release in 1 bottle | 13668-284-01 | Torrent PharmaceuticalsIndia | 10 September 2025 |
| 500 tablet, extended release in 1 bottle | 13668-284-05 | Torrent PharmaceuticalsIndia | 10 September 2025 |
| 8 tablet, extended release in 1 blister pack | 13668-284-22 | Torrent PharmaceuticalsIndia | 10 September 2025 |
| 80 tablet, extended release in 1 carton | 13668-284-23 | Torrent PharmaceuticalsIndia | 10 September 2025 |
| 30 tablet, extended release in 1 bottle | 13668-284-30 | Torrent PharmaceuticalsIndia | 10 September 2025 |
| 60 tablet, extended release in 1 bottle | 13668-284-60 | Torrent PharmaceuticalsIndia | 10 September 2025 |
| 100 tablet, extended release in 1 bottle | 60290-058-01 | Umedica LaboratoriesIndia | 20 August 2022 |
| 1000 tablet, extended release in 1 bottle | 60290-058-02 | Umedica LaboratoriesIndia | 20 August 2022 |
| 100 tablet, extended release in 1 bottle | 35561-355-12 | Bostal | 31 March 2022 |
| 500 tablet, extended release in 1 bottle | 35561-355-13 | Bostal | 9 April 2025 |
| 125729 tablet, extended release in 1 drum | 35561-355-99 | Bostal | 27 April 2025 |
| 60 tablet, extended release in 1 bottle | 62135-927-60 | Chartwell RX | 6 November 2024 |
| 100 tablet, extended release in 1 bottle | 42806-274-01 | Epic Pharma | 3 June 2024 |
| 100 tablet, extended release in 1 bottle, plastic | 50742-257-01 | Ingenus Pharmaceuticals | 1 August 2023 |
| 100 tablet, extended release in 1 bottle | 16571-680-01 | Rising Pharma Holdings | 24 April 2020 |
| 100 tablet, extended release in 1 bottle | 0832-6022-11 | Upsher-Smith Laboratories | 13 April 2021 |
| 100 tablet, extended release in 1 bottle | 16714-063-01 | Northstar Rx | 1 February 2021 |
| 100 tablet, extended release in 1 bottle | 72603-886-01 | Northstar Rx | 24 February 2026 |
| 30 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack | 60687-973-21 | American Health Packaging | 29 September 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 March 1968 | 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 Carbamazepine 100 mg extended-release tablet.
Other strengths and forms of Carbamazepine
Clinical summary
Carbamazepine is a mood stabilizer indicated as an anticonvulsant drug. It is available as extended-release tablets, tablets and extended-release capsules for oral use. MedsAcross supplies Carbamazepine 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 CarbamazepineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tegretol prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Carbamazepine 100 mg extended-release tablet for your hospital or patient?
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