Medicine
Clomiphene 50 mg tablet
Clomiphene 50 mg tablet is a generic prescription medicine for oral use, made by 8 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 tablets at controlled room temperature 15° to 30°C (59° to 86°F)…
Key facts
- Active ingredient (INN)
- Clomiphene
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 blister pack, 30 tablets, 3 blister pack and 11 more
- Manufacturers
- Camber PharmaceuticalsIndiaAccord HealthcareIndiaAcetris Pharma HoldingsIndiaRising Pharma HoldingsAdvagen PharmaANI PharmaceuticalsCosette Pharmaceuticals NC LaboratoriesAppco Pharma
- Origin register
- US FDA, United States
- Storage
- Store tablets at controlled room temperature 15° to 30°C (59° to 86°F). Protect from heat, light, and excessive humidity, and store in closed containers.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G03GB02 Clomiphene
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 November 2024
- Identifiers
- RxCUI 1093060DailyMed set ID 76c7550a-d527-4925-b19f-d8b52d567474, 2d257ec2-827c-4bc2-8f17-cf24520c3cad, 79f64995-7425-44c6-9f44-f7d20daeff65 +5NDC 52343-557, 55801-187, 16729-723 +5Application ANDA216739, ANDA219406, ANDA219781 +3
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 / 30 tablet in 1 blister pack | 16729-723-51 | Accord HealthcareIndia | 21 November 2025 |
| 30 tablet in 1 bottle | 52343-557-03 | Acetris Pharma HoldingsIndia | 29 June 2026 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 31722-541-32 | Camber PharmaceuticalsIndia | 31 August 2026 |
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 31722-541-33 | Camber PharmaceuticalsIndia | 31 August 2026 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 72888-213-08 | Advagen Pharma | 12 November 2024 |
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 72888-213-58 | Advagen Pharma | 12 November 2024 |
| 10 blister pack in 1 carton / 1 tablet in 1 blister pack | 70954-825-20 | ANI Pharmaceuticals | 17 October 2025 |
| 30 blister pack in 1 carton / 1 tablet in 1 blister pack | 70954-825-30 | ANI Pharmaceuticals | 17 October 2025 |
| 30 tablet in 1 bottle | 55801-187-01 | Appco Pharma | 18 November 2024 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 83390-107-09 | Cosette Pharmaceuticals NC Laboratories | 21 August 2025 |
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 83390-107-30 | Cosette Pharmaceuticals NC Laboratories | 21 August 2025 |
| 10 tablet in 1 bottle | 64980-690-01 | Rising Pharma Holdings | 15 September 2025 |
| 30 tablet in 1 bottle | 64980-690-03 | Rising Pharma Holdings | 19 November 2024 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 64980-690-90 | Rising Pharma Holdings | 15 September 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 1 February 1967 | 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
Alternatives
Other makers and brands of Clomiphene 50 mg tablet.
Clinical summary
Clomiphene is an estrogen agonist/antagonist indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. It is available as tablets for oral use. MedsAcross supplies Clomiphene 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 ClomipheneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Clomiphene Citrate prescribing information (Accord Healthcare) · U.S. National Library of Medicine, DailyMed
Need Clomiphene 50 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.