Quick answers
- What is Raltegravir used for?
- The FDA-approved label (Isentress, NuCare Pharmaceuticals,Inc., July 13, 2026) says: “ISENTRESS® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in patients 4 weeks of age and older. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response […]. ISENTRESS is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Raltegravir have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Raltegravir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Raltegravir been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Raltegravir?
- 6 companies list prescription products of Raltegravir in the FDA NDC Directory, including Merck Sharp & Dohme LLC, Camber Pharmaceuticals, Inc. and NuCare Pharmaceuticals, Inc..
What Raltegravir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ISENTRESS® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in patients 4 weeks of age and older. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response […]. ISENTRESS is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated …
— FDA label: Isentress, NuCare Pharmaceuticals,Inc., effective July 13, 2026. Read the full label on DailyMed →
The FDA has 3 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.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, chewable · Granule, for suspension |
|---|---|
| Route | Oral |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Isentress |
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 |
|---|---|---|
| raltegravir potassium 400 mg tablet, film coated | Brand: Isentress | $34.54 per tablet |
| raltegravir potassium 600 mg tablet, film coated | Brand: Isentress | $34.52 per tablet |
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.
- Merck Sharp & Dohme LLC5 products
- Camber Pharmaceuticals, Inc.1 product
- NuCare Pharmaceuticals, Inc.1 product
- A-S Medication Solutions1 product
- Proficient Rx LP1 product
- Lupin Pharmaceuticals, Inc.1 product
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 |
|---|---|---|---|
| NDA022145 ISENTRESS, ISENTRESS HD | Msd Sub Merck | October 12, 2007 | 31, latest May 18, 2021 2021: Labeling · 2020: Efficacy · 2018: Labeling |
| NDA203045 ISENTRESS | Msd Sub Merck | December 21, 2011 | 17, latest May 18, 2021 2021: Labeling · 2020: Efficacy · 2018: Labeling |
| NDA205786 ISENTRESS | Msd Sub Merck | December 20, 2013 | 8, latest May 18, 2021 2021: Labeling · 2020: Efficacy · 2018: Labeling |
Generic approvals (2)
- ANDA203540Hetero Labs Ltd III · December 19, 2024
- ANDA217990Lupin · May 6, 2025
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
| RxCUI (RxNorm) | 744842, 744846 |
|---|---|
| SPL set ID of the quoted label | 46ef8e2e-ae63-6a3c-e054-00144ff8d46c |
| FDA labels (SPL) | 3 |
| FDA applications | NDA022145, NDA203045, NDA205786, 2 ANDA |
| Active ingredients (FDA) | RALTEGRAVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Isentress, NuCare Pharmaceuticals,Inc., effective July 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 →