Medicine
Carbamazepine 300 mg extended-release capsule
Carbamazepine 300 mg extended-release capsule 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˚C to 25°C (68˚F to 77°F), excursions permitted to 15˚C to 30°C…
Key facts
- Active ingredient (INN)
- Carbamazepine
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 120 capsules, 30 blister pack, 30 capsules and 5 more
- Manufacturers
- Bryant Ranch PrepackANI PharmaceuticalsApotexAvPAKCouplerRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Store at 20˚C to 25°C (68˚F to 77°F), excursions permitted to 15˚C to 30°C (59˚F to 86°F).
- 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
- 23 March 2012
- Identifiers
- RxCUI 200131, 200133, 388311DailyMed set ID e91f9de3-3fdd-0a6b-71ce-53a2cc142816, e9d282f0-8bb7-4280-b83d-b70d83a04b93, 4db57051-13bb-4038-ae58-e4d7f541450d +5NDC 60505-2807, 70518-4492, 71335-2707 +5Application ANDA078986, ANDA076697
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 |
|---|---|---|---|
| 120 capsule, extended release in 1 bottle | 62559-486-12 | ANI Pharmaceuticals | 13 April 2026 |
| 120 capsule, extended release in 1 bottle | 60505-2807-7 | Apotex | 23 March 2012 |
| 120 capsule, extended release in 1 bottle | 71335-2707-1 | Bryant Ranch Prepack | 28 July 2025 |
| 120 capsule, extended release in 1 bottle | 71335-3001-1 | Bryant Ranch Prepack | 5 November 2025 |
| 120 capsule, extended release in 1 bottle | 72162-1715-2 | Bryant Ranch Prepack | 12 May 2025 |
| 30 blister pack in 1 box / 1 capsule, extended release in 1 blister pack | 50268-172-13 | AvPAK | 19 October 2021 |
| 30 capsule, extended release in 1 blister pack | 67046-1455-3 | Coupler | 7 February 2025 |
| 30 pouch in 1 box / 1 capsule, extended release in 1 pouch | 70518-4492-0 | Remedyrepack | 6 October 2025 |
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 300 mg extended-release capsule.
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 300 mg extended-release 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.