Medicine
Prempro 0.625 mg/5 mg tablet
Prempro 0.625 mg/5 mg tablet is a prescription medicine containing Estrogens, conjugated and Medroxyprogesterone for oral use, marketed by Wyeth Pharmaceuticals, 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)
- Estrogens, conjugated and Medroxyprogesterone
- Brand
- Prempro
- Strength
- 0.625 mg/5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 blister pack
- Marketing authorisation holder
- Wyeth Pharmaceuticals
- Manufacturer
- Wyeth Pharmaceuticals
- 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).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 December 2012
- Identifiers
- RxCUI 150840, 310197, 1000351 +7DailyMed set ID fd0c0836-5d23-2183-da81-9dc7f4287052NDC 0046-1108Application NDA020527
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 |
|---|---|---|---|
| 1 blister pack in 1 carton / 28 tablet, sugar coated in 1 blister pack | 0046-1108-11 | Wyeth Pharmaceuticals | 3 December 2012 |
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 30 December 1994 | 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 Estrogens, conjugated and Medroxyprogesterone
Clinical summary
Estrogens, conjugated and Medroxyprogesterone is a fixed-dose combination of an estrogen and a progestin indicated in a woman with a uterus for treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. MedsAcross supplies Estrogens, conjugated and Medroxyprogesterone 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 Estrogens, conjugated and MedroxyprogesteroneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Prempro prescribing information (Wyeth Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Prempro 0.625 mg/5 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.