Medicine
Carbatrol 100 mg extended-release capsule
Carbatrol 100 mg extended-release capsule is a prescription medicine containing Carbamazepine for oral use, marketed by Takeda Pharmaceuticals, 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 15-30°C (59-86°F). PROTECT FROM…
Key facts
- Active ingredient (INN)
- Carbamazepine
- Brand
- Carbatrol
- Strength
- 100 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 120 capsules
- Marketing authorisation holder
- Takeda Pharmaceuticals
- Manufacturer
- Takeda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). PROTECT FROM LIGHT AND 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
- 22 December 1999
- Identifiers
- RxCUI 200131, 200133, 308977 +3DailyMed set ID bc03e499-5bac-4293-bff4-6864153a624dNDC 54092-171Application NDA020712
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 120 capsule, extended release in 1 bottle | 54092-171-12 | Takeda Pharmaceuticals | 22 December 1999 |
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 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 Carbatrol 100 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.