Medicine
Phentermine and Topiramate 11.25 mg/69 mg extended-release capsule
Phentermine and Topiramate 11.25 mg/69 mg extended-release capsule 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 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Phentermine and Topiramate
- Brand
- Sold under the generic name
- Strength
- 11.25 mg/69 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 30 capsules
- Manufacturers
- Prasco LaboratoriesTeva Pharmaceuticals
- 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). Keep container tightly closed and protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 May 2025
- Identifiers
- RxCUI 1302827, 1302839, 1302850 +1DailyMed set ID 876bd763-13fa-481e-b579-c2fc44dbf3c2, 918df93d-e033-4419-adcc-e21655ef8158NDC 66993-782, 0480-2299Application NDA022580, ANDA204982
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 capsule, extended release in 1 bottle | 0480-2299-56 | Teva Pharmaceuticals | 7 May 2025 |
| 30 capsule, extended release in 1 bottle | 66993-782-30 | Prasco Laboratories | 1 June 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 17 July 2012 | Drugs@FDA |
| EU (EMA) | Refused | EMA medicines data |
| 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 Phentermine and Topiramate 11.25 mg/69 mg extended-release capsule.
Other strengths and forms of Phentermine and Topiramate
Clinical summary
Phentermine and Topiramate is a fixed-dose combination medicine indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults. MedsAcross supplies Phentermine and Topiramate 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 Phentermine and TopiramateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- phentermine and topiramate prescribing information (Prasco Laboratories) · U.S. National Library of Medicine, DailyMed
Need Phentermine and Topiramate 11.25 mg/69 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.