Quick answers
- What is Kaletra?
- Kaletra is a brand name of Lopinavir and ritonavir, a prescription medicine. The FDA NDC Directory lists 3 Kaletra products in 3 strengths and forms.
- Who makes Kaletra?
- Abbvie holds the FDA application for Kaletra (NDA021251, approved September 15, 2000).
- Is there a generic or store brand of Kaletra?
- Yes. The FDA NDC Directory lists 6 other products with the same active ingredients, strength and form as a Kaletra product, 6 of them generic. Ask your pharmacist whether one is right for you.
- Has Kaletra been recalled?
- No recall linked to Kaletra products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Kaletra is
Each Kaletra 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.
Lopinavir and ritonavir · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| lopinavir 100 mg · ritonavir 25 mg tablet, film coated (oral) | Kaletra | 3 products, 3 companies | DailyMed |
| lopinavir 200 mg · ritonavir 50 mg tablet, film coated (oral) | Kaletra | 3 products, 3 companies | DailyMed |
| lopinavir 80 mg/mL · ritonavir 20 mg/mL solution (oral) | Kaletra | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Lopinavir and ritonavir →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Kaletra
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Kaletra products.
- AbbVie Inc.3 products
Recalls
No recall linked to Kaletra 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.