FDA label
What is lamivudine used for?
The FDA-approved uses of lamivudine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation.”
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Lamivudine, tablet, film coated
Indications and Usage, quoted from the label by Apotex Corp. (ANDA202941). Cross-references to other label sections are left out.
Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation.
The following points should be considered when initiating therapy with lamivudine tablets (HBV):
- Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets (HBV) should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
- Lamivudine tablets (HBV) have not been evaluated in patients co-infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis delta virus.
- Lamivudine tablets (HBV) have not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.
Source: DailyMed label, set id 87095352-c088-74b1-7be0-d3e293a90611, version 12, effective September 14, 2026. NDC 60505-3250, one of 20 listings for this product.
Lamivudine Oral, solution
Indications and Usage, quoted from the label by Chartwell Govermental & Specialty RX, LLC. (ANDA203564). Cross-references to other label sections are left out.
Lamivudine oral solution, USP is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Limitations of Use:
- The dosage of this product is for HIV-1 and not for HBV.
Source: DailyMed label, set id b23aea53-324b-4ff2-8736-639e4045e388, version 2, effective January 2, 2026. NDC 68999-706, one of 4 listings for this product.
Questions
What is lamivudine used for?
The FDA label says: “Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation.”
What drug class is lamivudine?
FDA lists lamivudine in the Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Lamivudine
- Is Lamivudine a controlled substance?Federal schedule
- Generic for EpivirFDA Orange Book
- Generic for Epivir-hbvFDA Orange Book
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- NDC 49702-203Lamivudine NDC record
- NDC 49702-204Lamivudine NDC record
- NDC 49702-205Lamivudine NDC record