Medicine
Alendronate 35 mg tablet
Alendronate 35 mg tablet is a generic prescription medicine for oral use, made by 10 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 to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Alendronate
- Brand
- Sold under the generic name
- Strength
- 35 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 blister pack, 3 blister pack, 10 blister pack and 18 more
- Manufacturers
- Aurobindo PharmaIndiaCiplaIndiaHangzhou Minsheng Binjiang PharmaceuticalNorthStar RxAmneal Pharmaceuticals of New YorkMarlex PharmaceuticalsRising Pharma HoldingsA-S Medication SolutionsExelan PharmaceuticalsRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Store in a well-closed container.
- 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
- 6 February 2008
- Identifiers
- RxCUI 904396, 904419, 904431 +2DailyMed set ID 4323d3aa-cbb0-41e2-aba7-7a94a0516993, a24fd39c-34a7-4de2-9439-781e612189ca, 873442b0-1932-4fa6-ba25-b4d3505f4128 +7NDC 16714-632, 60723-207, 50090-5474 +7Application ANDA090124, ANDA090258, ANDA076768 +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 in 1 blister pack | 65862-328-04 | Aurobindo PharmaIndia | 4 August 2008 |
| 3 blister pack in 1 carton / 4 tablet in 1 blister pack | 65862-328-08 | Aurobindo PharmaIndia | 4 August 2008 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 65862-328-10 | Aurobindo PharmaIndia | 4 August 2008 |
| 5 blister pack in 1 carton / 4 tablet in 1 blister pack | 65862-328-20 | Aurobindo PharmaIndia | 4 August 2008 |
| 1 blister pack in 1 carton / 4 tablet in 1 blister pack | 69097-223-16 | CiplaIndia | 4 August 2008 |
| 3 blister pack in 1 carton / 4 tablet in 1 blister pack | 69097-223-76 | CiplaIndia | 4 August 2008 |
| 12 blister pack in 1 carton / 1 tablet in 1 blister pack | 0115-1679-26 | Amneal Pharmaceuticals of New York | 6 February 2008 |
| 4 blister pack in 1 carton / 1 tablet in 1 blister pack | 0115-1679-34 | Amneal Pharmaceuticals of New York | 6 February 2008 |
| 3 blister pack in 1 carton / 4 tablet in 1 blister pack | 76282-681-46 | Exelan Pharmaceuticals | 2 February 2021 |
| 1 blister pack in 1 carton / 4 tablet in 1 blister pack | 60723-207-31 | Hangzhou Minsheng Binjiang Pharmaceutical | 5 December 2017 |
| 3 blister pack in 1 carton / 4 tablet in 1 blister pack | 60723-207-32 | Hangzhou Minsheng Binjiang Pharmaceutical | 5 December 2017 |
| 2 blister pack in 1 carton / 10 tablet in 1 blister pack | 60723-207-33 | Hangzhou Minsheng Binjiang Pharmaceutical | 5 December 2017 |
| 3 blister pack in 1 carton / 4 tablet in 1 blister pack | 64980-341-12 | Rising Pharma Holdings | 4 August 2008 |
| 1 blister pack in 1 carton / 4 tablet in 1 blister pack | 64980-341-14 | Rising Pharma Holdings | 4 August 2008 |
| 1 blister pack in 1 carton / 4 tablet in 1 blister pack | 50090-5474-0 | A-S Medication Solutions | 2 March 2021 |
| 3 blister pack in 1 carton / 4 tablet in 1 blister pack | 10135-718-12 | Marlex Pharmaceuticals | 1 December 2020 |
| 1 blister pack in 1 carton / 4 tablet in 1 blister pack | 10135-718-44 | Marlex Pharmaceuticals | 1 December 2020 |
| 1 blister pack in 1 carton / 4 tablet in 1 blister pack | 16714-632-01 | NorthStar Rx | 4 August 2008 |
| 5 blister pack in 1 carton / 4 tablet in 1 blister pack | 16714-632-02 | NorthStar Rx | 4 August 2008 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 16714-632-11 | NorthStar Rx | 4 August 2008 |
| 3 blister pack in 1 carton / 4 tablet in 1 blister pack | 70518-1192-1 | Remedyrepack | 12 January 2024 |
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 29 September 1995 | 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 Alendronate
Clinical summary
Alendronate is a bisphosphonate indicated for treatment and prevention of osteoporosis in postmenopausal women, among other approved uses. It is available as tablets, oral solution and effervescent tablets. MedsAcross supplies Alendronate 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 AlendronateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- FOSAMAX prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
Need Alendronate 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.