Medicine
Risedronate 35 mg tablet
Risedronate 35 mg tablet is a generic prescription medicine for oral use, made by 5 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).
Key facts
- Active ingredient (INN)
- Risedronate
- Brand
- Sold under the generic name
- Strength
- 35 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 blister pack, 3 blister pack, 12 blister pack and 6 more
- Manufacturers
- Aurobindo PharmaIndiaMacleods PharmaceuticalsIndiaApotexTeva PharmaceuticalsProficient Rx
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M05BA07 Risedronate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 2015
- Identifiers
- RxCUI 905024, 905032, 905041 +4DailyMed set ID dddcd321-4d2e-4643-bf3c-7b752b33ba39, 89896dfe-f69d-4cb3-bb71-7a7c611071fa, 81702f21-3117-49ce-8e9b-2aa2648ba7c3 +2NDC 0093-3098, 65862-519, 71205-714 +2Application ANDA077132, ANDA200296, ANDA090877 +1
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 |
|---|---|---|---|
| 1 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack | 65862-519-04 | Aurobindo PharmaIndia | 30 November 2015 |
| 3 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack | 65862-519-08 | Aurobindo PharmaIndia | 30 November 2015 |
| 1 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack | 33342-109-37 | Macleods PharmaceuticalsIndia | 9 December 2015 |
| 3 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack | 33342-109-50 | Macleods PharmaceuticalsIndia | 9 December 2015 |
| 1 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack | 60505-3165-0 | Apotex | 30 November 2015 |
| 3 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack | 60505-3165-2 | Apotex | 30 November 2015 |
| 12 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 0093-3098-29 | Teva Pharmaceuticals | 1 June 2015 |
| 4 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 0093-3098-44 | Teva Pharmaceuticals | 1 June 2015 |
| 1 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack | 71205-714-04 | Proficient Rx | 10 November 2022 |
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 27 March 1998 | 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 Risedronate
Clinical summary
Risedronate 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 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 RisedronateFor 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 (Teva Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Risedronate 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.