Quick answers
- What is Estradiol valerate used for?
- The FDA-approved label (Delestrogen, Par Health USA, LLC, May 13, 2026) says: “DELESTROGEN (estradiol valerate injection, USP) is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Estradiol valerate have a boxed warning?
- Yes. The FDA label for Delestrogen has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Estradiol valerate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Estradiol valerate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Estradiol valerate?
- 4 companies list prescription products of Estradiol valerate in the FDA NDC Directory, including Xiromed, LLC, Hikma Pharmaceuticals USA Inc. and American Regent, Inc..
What Estradiol valerate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DELESTROGEN (estradiol valerate injection, USP) is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. …
— FDA label: Delestrogen, Par Health USA, LLC, effective May 13, 2026. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
4 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Intramuscular |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Delestrogen |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| estradiol valerate 10 mg/mL injection | Generic | $18.37 per mL |
| estradiol valerate 10 mg/mL injection | Brand: Delestrogen | $25.50 per mL |
| estradiol valerate 20 mg/mL injection | Generic | $22.96 per mL |
| estradiol valerate 20 mg/mL injection | Brand: Delestrogen | $35.78 per mL |
| estradiol valerate 20 mg/mL injection, solution | Generic | $22.96 per mL |
| estradiol valerate 40 mg/mL injection | Generic | $37.82 per mL |
| estradiol valerate 40 mg/mL injection, solution | Generic | $37.82 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Xiromed, LLC3 products
- Hikma Pharmaceuticals USA Inc.3 products
- American Regent, Inc.2 products
- Par Health USA, LLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA009402 DELESTROGEN | Ph Health | July 15, 1954 | 27, latest February 15, 2024 2024: Labeling · 2022: Labeling · 2017: Labeling |
Generic approvals (3)
- ANDA090920Am Regent · January 19, 2010
- ANDA203723Hikma · April 21, 2020
- ANDA216656Xiromed · April 28, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Delestrogen, Par Health USA, LLC, effective May 13, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →