Quick answers
- What is Entecavir used for?
- The FDA-approved label (Baraclude, E.R. Squibb & Sons, L.L.C., November 6, 2019) says: “BARACLUDE ® (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Entecavir have a boxed warning?
- Yes. The FDA label for Baraclude has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Entecavir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Entecavir been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started September 24, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Entecavir?
- 16 companies list prescription products of Entecavir in the FDA NDC Directory, including Epic Pharma, LLC, E.R. Squibb & Sons, L.L.C. and Yaopharma Co., Ltd..
What Entecavir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BARACLUDE ® (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. …
— FDA label: Baraclude, E.R. Squibb & Sons, L.L.C., effective November 6, 2019. Read the full label on DailyMed →
The FDA has 15 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 →
14 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Solution |
|---|---|
| Route | Oral |
| Prescription products | 31 in the FDA NDC Directory |
| Brand names | Baraclude |
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 |
|---|---|---|
| entecavir 0.5 mg tablet | Generic | $0.2460 per tablet |
| entecavir 0.5 mg tablet, film coated | Generic | $0.2460 per tablet |
| entecavir 0.5 mg tablet, film coated | Brand: Baraclude | $44.19 per tablet |
| entecavir 1 mg tablet | Generic | $0.3579 per tablet |
| entecavir 1 mg tablet, film coated | Generic | $0.3579 per tablet |
| entecavir anhydrous 0.5 mg tablet | Generic | $0.2460 per tablet |
| entecavir anhydrous 0.5 mg tablet, film coated | Generic | $0.2460 per tablet |
| entecavir anhydrous 1 mg tablet | Generic | $0.3579 per tablet |
| entecavir anhydrous 1 mg tablet, film coated | Generic | $0.3579 per tablet |
NADAC list of November 4, 2026; these prices took effect between November 19, 2025 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.
- Epic Pharma, LLC4 products
- E.R. Squibb & Sons, L.L.C.3 products
- Yaopharma Co., Ltd.2 products
- Amneal Pharmaceuticals LLC2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Aurobindo Pharma Limited2 products
- Cipla USA Inc.2 products
- Zydus Lifesciences Limited2 products
- NorthStar RxLLC2 products
- Cameron Pharmaceuticals2 products
- Camber Pharmaceuticals, Inc.2 products
- Solco Healthcare LLC2 products
- American Health Packaging1 product
- Carlsbad Technology, Inc.1 product
- AvKARE1 product
- Golden State Medical Supply, 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 |
|---|---|---|---|
| NDA021797 BARACLUDE | Bristol Myers Squibb | March 29, 2005 | 19, latest August 18, 2026 2026: Labeling · 2019: Labeling · 2018: Labeling |
| NDA021798 BARACLUDE | Bristol Myers Squibb | March 29, 2005 | 18, latest August 18, 2026 2026: Labeling · 2019: Labeling · 2018: Labeling |
Generic approvals (10)
- ANDA205740Hetero Labs Ltd V · August 21, 2015
- ANDA206217Aurobindo Pharma · August 26, 2015
- ANDA206652Amneal Pharms · November 12, 2015
- ANDA206872Cipla · December 6, 2016
- ANDA206745Zydus Pharms · June 23, 2017
- ANDA208782Prinston Inc · October 10, 2017
- ANDA212126Brightgene · September 25, 2019
- ANDA212201Yaopharma Co Ltd · November 4, 2019
- ANDA208195Yung Shin Pharm · November 10, 2021
- ANDA216857Conba USA · December 23, 2024
Shortage status
The FDA drug shortage list does not show these products.
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.
-
September 24, 2025 · Class II · Ongoing · D-0001-2026
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. — Zydus Pharmaceuticals (USA) Inc
-
September 24, 2025 · Class II · Ongoing · D-0002-2026
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. — Zydus Pharmaceuticals (USA) Inc
-
September 4, 2025 · Class II · Ongoing · D-0657-2025
Failed Impurity/Degradation Specifications
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. — Zydus Pharmaceuticals (USA) Inc
-
September 4, 2025 · Class II · Ongoing · D-0656-2025
Failed Impurity/Degradation Specifications
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. — Zydus Pharmaceuticals (USA) Inc
-
July 20, 2017 · Class II · Terminated · D-1095-2017
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. N — Hetero USA 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Baraclude, E.R. Squibb & Sons, L.L.C., effective November 6, 2019; 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 →