Quick answers
- What is Emtricitabine used for?
- The FDA-approved label (Emtricitabine, Cipla USA Inc., August 18, 2026) says: “Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Emtricitabine, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Emtricitabine have a boxed warning?
- Yes. The FDA label for Emtricitabine has a boxed warning (“WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Emtricitabine?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated June 17, 2026). Ask your pharmacist about alternatives.
- Has Emtricitabine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started October 1, 2014 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Emtricitabine?
- 3 companies list prescription products of Emtricitabine in the FDA NDC Directory, including Gilead Sciences, Inc., Aurobindo Pharma Limited and Cipla USA Inc..
What Emtricitabine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Emtricitabine, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
— FDA label: Emtricitabine, Cipla USA Inc., effective August 18, 2026. Read the full label on DailyMed →
The FDA has 2 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. Its heading: WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Solution |
|---|---|
| Route | Oral |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Emtriva |
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 |
|---|---|---|
| emtricitabine 200 mg capsule | Generic | $12.67 per capsule |
| emtricitabine 200 mg capsule | Brand: Emtriva | $17.45 per capsule |
NADAC list of November 4, 2026; these prices took effect between July 22, 2026 and 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.
- Gilead Sciences, Inc.2 products
- Aurobindo Pharma Limited1 product
- Cipla USA 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 |
|---|---|---|---|
| NDA021500 EMTRIVA | Gilead | July 2, 2003 | 12, latest December 10, 2018 2018: Labeling · 2017: Labeling · 2014: Manufacturing (CMC) |
| NDA021896 EMTRIVA | Gilead | September 28, 2005 | 10, latest December 10, 2018 2018: Labeling · 2017: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (2)
- ANDA091168Cipla · July 2, 2018
- ANDA079188Aurobindo Pharma Ltd · March 15, 2023
Shortage status
To be discontinued · updated June 17, 2026 · first posted June 17, 2026
| Product | Emtriva, Oral Solution, 10 mg/1 mL (NDC 61958-0602-1) |
|---|---|
| Company | Gilead Sciences, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 1, 2014 · Class II · Terminated · D-0045-2015
Defective Container; leaking around the cap
Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA NDC 61958-0602-1 Gilead Sciences, Inc. Foster City, CA 94404. — Gilead Sciences, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 403875 |
|---|---|
| SPL set ID of the quoted label | a229c922-58eb-4795-9219-6cebb1779e35 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA021500, NDA021896, 2 ANDA |
| Active ingredients (FDA) | EMTRICITABINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Emtricitabine, Cipla USA Inc., effective August 18, 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 →