Medicine
Risedronate sodium hemi-pentahydrate 35 mg tablet
Risedronate sodium hemi-pentahydrate 35 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 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C…
Key facts
- Active ingredient (INN)
- Risedronate sodium hemi-pentahydrate
- Brand
- Sold under the generic name
- Strength
- 35 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 3 blister pack, 1 blister pack and 1 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaHangzhou Minsheng Binjiang Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°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
- 30 November 2015
- Identifiers
- RxCUI 905024, 905028, 905032 +4DailyMed set ID e0b5f0ed-ff40-4f0d-bb86-81a7ace9f339, d60a56cb-ef49-4447-9043-7b6879a20d75NDC 47335-668, 60723-041Application ANDA090886, ANDA207516
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 |
|---|---|---|---|
| 3 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack | 47335-668-62 | Sun Pharmaceutical IndustriesIndia | 30 November 2015 |
| 1 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack | 47335-668-68 | Sun Pharmaceutical IndustriesIndia | 30 November 2015 |
| 1 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack | 60723-041-04 | Hangzhou Minsheng Binjiang Pharmaceutical | 1 April 2019 |
| 3 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack | 60723-041-12 | Hangzhou Minsheng Binjiang Pharmaceutical | 1 April 2019 |
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
Other strengths and forms of Risedronate sodium hemi-pentahydrate
Clinical summary
Risedronate sodium hemi-pentahydrate is a bisphosphonate indicated for treatment and prevention of postmenopausal osteoporosis, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Risedronate sodium hemi-pentahydrate 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 sodium hemi-pentahydrateFor 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 (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
Need Risedronate sodium hemi-pentahydrate 35 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.