Quick answers
- What is Lamivudine used for?
- The FDA-approved label (Lamivudine, Camber Pharmaceuticals, Inc., July 29, 2026) 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 […]. The following points should be considered when initiating therapy with lamivudine tablets (HBV) …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lamivudine have a boxed warning?
- Yes. The FDA label for Lamivudine has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Lamivudine?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated October 19, 2026). Ask your pharmacist about alternatives.
- Has Lamivudine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lamivudine?
- 15 companies list prescription products of Lamivudine in the FDA NDC Directory, including Camber Pharmaceuticals, Inc., Apotex Corp. and Aurobindo Pharma Limited.
What Lamivudine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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) …
— FDA label: Lamivudine, Camber Pharmaceuticals, Inc., effective July 29, 2026. Read the full label on DailyMed →
The FDA has 17 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. Read it on the full label →
17 of 17 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Solution · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 29 in the FDA NDC Directory |
| Brand names | Epivir |
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 |
|---|---|---|
| lamivudine 10 mg/mL solution | Generic | $0.2176 per mL |
| lamivudine 100 mg tablet, film coated | Generic | $9.08 per tablet |
| lamivudine 150 mg tablet, film coated | Generic | $0.4801 per tablet |
| lamivudine 300 mg tablet, film coated | Generic | $1.42 per tablet |
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.
- Camber Pharmaceuticals, Inc.4 products
- Apotex Corp.3 products
- Aurobindo Pharma Limited3 products
- ViiV Healthcare Company3 products
- Golden State Medical Supply, Inc.3 products
- Macleods Pharmaceuticals Limited2 products
- Strides Pharma Science Limited2 products
- Ingenus Pharmaceuticals, LLC2 products
- Chartwell Govermental & Specialty RX, LLC.1 product
- American Health Packaging1 product
- Coupler LLC1 product
- Chartwell RX, LLC1 product
- Major Pharmaceuticals1 product
- Rising Pharma Holdings, Inc.1 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 |
|---|---|---|---|
| NDA020564 EPIVIR | Viiv Hlthcare | November 17, 1995 | 32, latest May 10, 2019 2019: Labeling · 2018: Labeling · 2017: Labeling |
| NDA020596 EPIVIR | Viiv Hlthcare | November 17, 1995 | 32, latest May 10, 2019 2019: Labeling · 2018: Labeling · 2017: Labeling |
Generic approvals (12)
- ANDA091606Apotex · December 2, 2011
- ANDA202941Apotex · January 2, 2014
- ANDA203260Hetero Labs Ltd V · January 2, 2014
- ANDA203277Hetero Labs Ltd V · January 6, 2014
- ANDA203564Chartwell Molecular · October 31, 2014
- ANDA205217Lupin · December 18, 2014
- ANDA077464Aurobindo Pharma · November 21, 2016
- ANDA077695Aurobindo Pharma · November 21, 2016
- ANDA206974Somerset Theraps LLC · November 21, 2016
- ANDA090457Strides Pharma · April 19, 2018
- ANDA211306Annora · March 21, 2019
- ANDA090198Macleods Pharms · May 1, 2019
Shortage status
To be discontinued · updated October 19, 2026 · first posted October 19, 2026
| Product | Epivir, Tablet, 150 mg (NDC 49702-203-18) |
|---|---|
| Company | ViiV Healthcare Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 199147, 199148, 205328, 349491 |
|---|---|
| SPL set ID of the quoted label | 6bd6b9da-df69-46db-813e-4e7f3bdecf95 |
| FDA labels (SPL) | 17 |
| FDA applications | NDA020564, NDA020596, 12 ANDA |
| Active ingredients (FDA) | LAMIVUDINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lamivudine, Camber Pharmaceuticals, Inc., effective July 29, 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 →