Medicine
Estradiol valerate 50 mg/5 mL injection
Estradiol valerate 50 mg/5 mL injection is a generic prescription medicine for intramuscular 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 between 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Estradiol valerate
- Brand
- Sold under the generic name
- Strength
- 50 mg/5 mL
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 1 vial of 5 mL, 5 mL
- Manufacturers
- Hikma PharmaceuticalsXiromed
- Origin register
- US FDA, United States
- Storage
- Store between 20° to 25°C (68° to 77°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
- 21 April 2020
- Identifiers
- RxCUI 310189, 310190, 310191DailyMed set ID 2e5c7559-7420-168d-6272-92bb4d20035d, 66f40ab0-4432-4e85-b709-a0bc076868c6NDC 70700-273, 0143-9289Application ANDA216656, ANDA203723
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 vial in 1 carton / 5 mL in 1 vial | 0143-9289-01 | Hikma Pharmaceuticals | 21 April 2020 |
| 5 mL in 1 vial, multi-dose | 70700-273-22 | Xiromed | 1 May 2023 |
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 15 July 1954 | 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 Estradiol valerate 50 mg/5 mL injection.
Other strengths and forms of Estradiol valerate
Clinical summary
Estradiol valerate is an estrogen indicated in the 1. It is available as injection for intramuscular use. MedsAcross supplies Estradiol valerate 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 Estradiol valerateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Delestrogen prescribing information (Par Health) · U.S. National Library of Medicine, DailyMed
Need Estradiol valerate 50 mg/5 mL injection 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.