Quick answers
- What is Eligard?
- Eligard is a brand name of Leuprolide acetate, a prescription medicine. The FDA NDC Directory lists 4 Eligard products in 4 strengths and forms.
- Who makes Eligard?
- Tolmar holds the FDA application for Eligard (NDA021343, approved January 23, 2002).
- Is there a generic or store brand of Eligard?
- Yes. The FDA NDC Directory lists 5 other products with the same active ingredients, strength and form as a Eligard product, 4 of them generic. Ask your pharmacist whether one is right for you.
- Has Eligard been recalled?
- No recall linked to Eligard products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Eligard is
Each Eligard product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Leuprolide acetate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| leuprolide acetate 22.5 mg/0.375 mL injection, suspension, extended release (subcutaneous) | Eligard | 1 product, 1 company | DailyMed |
| leuprolide acetate 30 mg/0.5 mL injection, suspension, extended release (subcutaneous) | Eligard | 1 product, 1 company | DailyMed |
| leuprolide acetate 45 mg/0.375 mL injection, suspension, extended release (subcutaneous) | Eligard | 2 products, 2 companies | DailyMed |
| leuprolide acetate 7.5 mg/0.25 mL injection, suspension, extended release (subcutaneous) | Eligard | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Leuprolide acetate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Eligard
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Eligard products.
- TOLMAR Inc.4 products
Recalls
No recall linked to Eligard products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.