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BARACLUDE

entecavir · Tablet, Film Coated

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
BARACLUDE
Generic name
entecavir
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
E.R. Squibb & Sons, L.L.C.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Entecavir .5 mg/1 485434 View
Entecavir 1 mg/1 485434 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] EPC All 22 members
Nucleoside Analog [EXT] EPC All 34 members
Nucleoside Reverse Transcriptase Inhibitors [MoA] MoA All 29 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021797
Application type
NDA · New Drug Application
Approval date
March 29, 2005
Sponsor
BRISTOL MYERS SQUIBB
Products on application
2
Submissions recorded
20
Products approved under application 021797.
Product Trade name Form Strength Ingredient Status TE Flags
021797-001 BARACLUDE TABLET ENTECAVIR Prescription AB RLD
021797-002 BARACLUDE TABLET ENTECAVIR Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 021797.
Type No. Action Status Date Review
Supplement 27 Labeling Approved August 18, 2026 Standard
Supplement 23 Labeling Approved November 6, 2019 Standard
Supplement 21 Labeling Approved December 20, 2018 Standard
Supplement 19 Labeling Approved June 22, 2018 Standard
Supplement 18 Efficacy Approved March 20, 2014 Priority
Supplement 17 Labeling Approved December 19, 2013 Standard
Supplement 16 Manufacturing (CMC) Approved June 18, 2013 Priority
Supplement 15 Manufacturing (CMC) Approved April 16, 2013 Priority
Supplement 14 Efficacy Approved October 12, 2012 Standard
Supplement 13 Efficacy Approved October 12, 2012 Standard
Supplement 11 Labeling Approved December 28, 2010 Unknown
Supplement 10 Efficacy Approved October 15, 2010 Standard
Supplement 8 Efficacy Approved July 16, 2009 Unknown
Supplement 9 Labeling Approved February 25, 2009 Standard
Supplement 5 Efficacy Approved July 25, 2008 Standard
Supplement 6 Labeling Approved June 3, 2008 Standard
Supplement 3 Labeling Approved July 24, 2007 Standard
Supplement 2 Efficacy Approved March 27, 2007 Unknown
Supplement 1 Efficacy Approved February 23, 2007 Unknown
Original application 1 Type 1 - New Molecular Entity Approved March 29, 2005 Priority

Review documents

  • 0 · Supplement · August 20, 2026
  • 0 · Supplement · August 19, 2026
  • 0 · Supplement · November 19, 2019
  • 0 · Supplement · November 12, 2019
  • 0 · Supplement · December 21, 2018
  • 0 · Supplement · December 21, 2018
  • 0 · Supplement · July 7, 2018
  • 0 · Supplement · June 27, 2018
  • 0 · Supplement · March 25, 2014
  • 0 · Supplement · March 21, 2014
  • 0 · Supplement · December 23, 2013
  • 0 · Supplement · December 20, 2013
  • 0 · Supplement · May 31, 2013
  • 0 · Supplement · October 15, 2012
  • 0 · Supplement · October 15, 2012
  • 0 · Supplement · October 15, 2012
  • 0 · Supplement · October 15, 2012
  • 0 · Supplement · January 4, 2011
  • 0 · Supplement · December 28, 2010
  • 0 · Supplement · October 29, 2010
  • 0 · Supplement · June 28, 2010
  • 0 · Supplement · July 24, 2009
  • 0 · Supplement · July 22, 2009
  • 0 · Supplement · March 17, 2009
  • 0 · Supplement · February 27, 2009
  • 0 · Supplement · August 13, 2008
  • 0 · Supplement · July 31, 2008
  • 0 · Supplement · June 6, 2008
  • 0 · Supplement · July 27, 2007
  • 0 · Supplement · July 27, 2007

Adverse event reports

Source: openFDA FAERS
11,608
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ENTECAVIR. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0003-1611-12 0003-1611 E.R. Squibb & Sons, L.L.C. 1 BOTTLE in 1 CARTON (0003-1611-12) / 30 TABLET, FILM COATED in 1 BOTTLE March 29, 2005
0003-1612-12 0003-1612 E.R. Squibb & Sons, L.L.C. 1 BOTTLE in 1 CARTON (0003-1612-12) / 30 TABLET, FILM COATED in 1 BOTTLE March 29, 2005
0003-1611 0003-1611 E.R. Squibb & Sons, L.L.C. — March 29, 2005
0003-1612 0003-1612 E.R. Squibb & Sons, L.L.C. — March 29, 2005

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.