Medicine
Risedronate and Risedronate sodium hemipentahydrate 4.9 mg/30.1 mg tablet
Risedronate and Risedronate sodium hemipentahydrate 4.9 mg/30.1 mg tablet is a generic prescription medicine for oral use, 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 controlled room temperature 20° to 25° C (68° to 77° F).
Key facts
- Active ingredient (INN)
- Risedronate and Risedronate sodium hemipentahydrate
- Brand
- Sold under the generic name
- Strength
- 4.9 mg/30.1 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 4 tablets
- Manufacturer
- Mylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20° to 25° C (68° to 77° F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 May 2002
- Identifiers
- RxCUI 905024, 905028, 905092 +1DailyMed set ID f715718a-407d-4e2a-9834-74a8f1361d03NDC 59762-0405Application NDA020835
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 |
|---|---|---|---|
| 4 tablet, film coated in 1 dose pack | 59762-0405-4 | Mylan Pharmaceuticals | 17 May 2002 |
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 |
| 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 Risedronate and Risedronate sodium hemipentahydrate 4.9 mg/30.1 mg tablet.
Other strengths and forms of Risedronate and Risedronate sodium hemipentahydrate
Clinical summary
Risedronate and Risedronate sodium hemipentahydrate is a fixed-dose combination medicine indicated for treatment and prevention of postmenopausal osteoporosis, among other approved uses. It is available as tablets and delayed-release tablets for oral use. MedsAcross supplies Risedronate and Risedronate sodium hemipentahydrate 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 Risedronate and Risedronate sodium hemipentahydrateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Risedronate Sodium prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Risedronate and Risedronate sodium hemipentahydrate 4.9 mg/30.1 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.