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EPIVIR

lamivudine · 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
EPIVIR
Generic name
lamivudine
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
ViiV Healthcare Company
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
Lamivudine 150 mg/1 199147 View
Lamivudine 300 mg/1 199147 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
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] EPC All 25 members
Nucleoside Reverse Transcriptase Inhibitors [MoA] MoA All 29 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020564
Application type
NDA · New Drug Application
Approval date
November 17, 1995
Sponsor
VIIV HLTHCARE
Products on application
2
Submissions recorded
34
Products approved under application 020564.
Product Trade name Form Strength Ingredient Status TE Flags
020564-001 EPIVIR TABLET LAMIVUDINE Prescription AB RLD
020564-003 EPIVIR TABLET LAMIVUDINE 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 020564.
Type No. Action Status Date Review
Supplement 39 Labeling Approved May 10, 2019 Standard
Supplement 38 Labeling Approved April 27, 2018 Standard
Supplement 37 Labeling Approved September 25, 2017 Standard
Supplement 36 Efficacy Approved July 20, 2016 Priority
Supplement 35 Labeling Approved September 30, 2015 Standard
Supplement 33 Efficacy Approved March 23, 2015 Standard
Supplement 34 Labeling Approved February 19, 2015 Standard
Supplement 32 Manufacturing (CMC) Approved December 18, 2012 —
Supplement 31 Labeling Approved November 18, 2011 901 Required
Supplement 28 Efficacy Approved February 1, 2008 Priority
Supplement 26 Labeling Approved October 25, 2006 Standard
Supplement 24 Labeling Approved June 13, 2006 Standard
Supplement 20 Labeling Approved November 22, 2004 Standard
Original application 20 Type 1 - New Molecular Entity Approved November 22, 2004 —
Supplement 21 Labeling Approved September 29, 2004 Standard
Supplement 19 Labeling Approved November 13, 2003 Standard
Supplement 14 Labeling Approved October 8, 2002 Standard
Supplement 17 Manufacturing (CMC) Approved September 13, 2002 —
Supplement 15 Efficacy Approved June 24, 2002 Standard
Supplement 16 Labeling Approved March 1, 2002 Standard
Supplement 13 Labeling Approved June 19, 2001 Standard
Supplement 12 Labeling Approved March 6, 2001 Standard
Supplement 11 Labeling Approved January 5, 2001 Standard
Supplement 7 Efficacy Approved March 23, 1999 Standard
Supplement 10 Labeling Approved March 8, 1999 Standard
Supplement 9 Labeling Approved March 8, 1999 Standard
Supplement 8 Manufacturing (CMC) Approved November 5, 1998 —
Supplement 5 Manufacturing (CMC) Approved February 3, 1998 —
Supplement 6 Labeling Approved December 15, 1997 Standard
Supplement 4 Labeling Approved December 15, 1997 Standard
Supplement 3 Manufacturing (CMC) Approved October 31, 1997 —
Supplement 2 Efficacy Approved April 11, 1997 Priority
Supplement 1 Labeling Approved July 31, 1996 Standard
Original application 1 Type 1 - New Molecular Entity Approved November 17, 1995 Priority

Review documents

  • 0 · Supplement · May 15, 2019
  • 0 · Supplement · May 14, 2019
  • 0 · Original application · February 15, 2019
  • 0 · Supplement · May 7, 2018
  • 0 · Supplement · May 1, 2018
  • 0 · Supplement · October 12, 2017
  • 0 · Supplement · July 22, 2016
  • 0 · Supplement · July 21, 2016
  • 0 · Supplement · October 7, 2015
  • 0 · Supplement · October 2, 2015
  • 0 · Supplement · April 14, 2015
  • 0 · Supplement · March 26, 2015
  • 0 · Supplement · February 24, 2015
  • 0 · Supplement · February 20, 2015
  • 0 · Supplement · December 2, 2011
  • 0 · Supplement · November 22, 2011
  • 0 · Supplement · February 14, 2008
  • 0 · Supplement · February 7, 2008
  • 0 · Supplement · September 26, 2007
  • 0 · Supplement · September 26, 2007
  • 0 · Supplement · September 26, 2007
  • 0 · Supplement · September 26, 2007
  • 0 · Supplement · October 31, 2006
  • 0 · Supplement · October 26, 2006
  • 0 · Supplement · June 20, 2006
  • 0 · Supplement · June 14, 2006
  • 0 · Supplement · January 6, 2005
  • 0 · Supplement · December 3, 2004
  • 0 · Supplement · December 2, 2004
  • 0 · Supplement · October 4, 2004

Adverse event reports

Source: openFDA FAERS
42,327
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: LAMIVUDINE. 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
49702-203-18 49702-203 ViiV Healthcare Company 60 TABLET, FILM COATED in 1 BOTTLE (49702-203-18) October 4, 2010
49702-204-13 49702-204 ViiV Healthcare Company 30 TABLET, FILM COATED in 1 BOTTLE (49702-204-13) October 4, 2010
49702-203 49702-203 ViiV Healthcare Company — October 4, 2010
49702-204 49702-204 ViiV Healthcare Company — October 4, 2010

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.