Medicine
Carbamazepine 100 mg tablet
Carbamazepine 100 mg tablet is a generic prescription medicine for oral use, made by 2 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 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC to…
Key facts
- Active ingredient (INN)
- Carbamazepine
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets and 1 more
- Manufacturers
- Umedica LaboratoriesIndiaNivagen Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC to 30ºC (59ºF to 86ºF). 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
- 21 April 2020
- Identifiers
- RxCUI 197441, 308979DailyMed set ID f3465f71-8931-43b6-baea-eac7046a4400, e68998cb-5f91-4d7e-85a6-555efb8b0384NDC 60290-034, 75834-220Application ANDA207798
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 in 1 bottle | 60290-034-02 | Umedica LaboratoriesIndia | 21 April 2020 |
| 1000 tablet in 1 bottle | 60290-034-03 | Umedica LaboratoriesIndia | 21 April 2020 |
| 1000 tablet in 1 bottle | 75834-220-00 | Nivagen Pharmaceuticals | 21 April 2020 |
| 100 tablet in 1 bottle | 75834-220-01 | Nivagen Pharmaceuticals | 21 April 2020 |
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
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 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.