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Tamiflu

oseltamivir phosphate · Capsule

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
Tamiflu
Generic name
oseltamivir phosphate
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
Genentech, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
3
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
Oseltamivir Phosphate 30 mg/1 312122 View
Oseltamivir Phosphate 75 mg/1 312122 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
5

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
Neuraminidase Inhibitor [EPC] EPC 9 members — no class page
Neuraminidase Inhibitors [MoA] MoA 9 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021087
Application type
NDA · New Drug Application
Approval date
October 27, 1999
Sponsor
ROCHE
Products on application
3
Submissions recorded
64
Products approved under application 021087.
Product Trade name Form Strength Ingredient Status TE Flags
021087-001 TAMIFLU CAPSULE OSELTAMIVIR PHOSPHATE Prescription AB RLD RS
021087-002 TAMIFLU CAPSULE OSELTAMIVIR PHOSPHATE Discontinued AB RLD
021087-003 TAMIFLU CAPSULE OSELTAMIVIR PHOSPHATE Discontinued AB RLD

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 021087.
Type No. Action Status Date Review
Supplement 71 Efficacy Approved August 2, 2019 Standard
Supplement 70 Labeling Approved December 12, 2018 Standard
Supplement 69 Labeling Approved April 4, 2018 Standard
Supplement 68 Labeling Approved June 20, 2016 Standard
Supplement 67 Manufacturing (CMC) Approved December 15, 2014 Priority
Supplement 60 Labeling Approved November 26, 2014 Standard
Supplement 65 Labeling Approved October 14, 2014 Standard
Supplement 66 Manufacturing (CMC) Approved October 8, 2014 Priority
Supplement 64 Labeling Approved May 30, 2014 Standard
Supplement 63 Manufacturing (CMC) Approved December 20, 2013 Priority
Supplement 61 Labeling Approved January 29, 2013 Standard
Supplement 62 Efficacy Approved December 21, 2012 Priority
Supplement 59 Labeling Approved August 16, 2012 Standard
Supplement 56 Labeling Approved March 21, 2011 Standard
Supplement 57 Labeling Approved February 7, 2011 901 Required
Supplement 45 Labeling Approved December 15, 2010 Standard
Supplement 55 Labeling Approved November 5, 2010 Standard
Supplement 49 Efficacy Approved February 22, 2010 Priority
Supplement 48 Labeling Approved February 22, 2010 Standard
Supplement 47 Labeling Approved September 25, 2008 Standard
Supplement 46 Labeling Approved June 10, 2008 Standard
Supplement 43 Manufacturing (CMC) Approved May 5, 2008 Priority
Supplement 42 Labeling Approved January 17, 2008 Standard
Supplement 44 Manufacturing (CMC) Approved December 3, 2007 Priority
Supplement 41 Labeling Approved October 5, 2007 Standard
Supplement 40 Manufacturing (CMC) Approved July 2, 2007 N/A
Supplement 39 Manufacturing (CMC) Approved March 26, 2007 Priority
Supplement 38 Manufacturing (CMC) Approved March 22, 2007 Priority
Supplement 37 Manufacturing (CMC) Approved March 12, 2007 Priority
Supplement 36 Manufacturing (CMC) Approved February 27, 2007 Priority
Supplement 35 Manufacturing (CMC) Approved February 1, 2007 Priority
Supplement 34 Manufacturing (CMC) Approved December 19, 2006 Priority
Supplement 33 Labeling Approved November 13, 2006 Standard
Supplement 31 Manufacturing (CMC) Approved June 23, 2006 Priority
Supplement 30 Efficacy Approved December 21, 2005 Unknown
Supplement 29 Manufacturing (CMC) Approved December 1, 2005 Priority
Supplement 25 Labeling Approved October 27, 2005 Standard
Supplement 28 Manufacturing (CMC) Approved October 14, 2005 Priority
Supplement 27 Manufacturing (CMC) Approved October 14, 2005 Priority
Supplement 26 Labeling Approved August 16, 2005 Standard
Supplement 24 Manufacturing (CMC) Approved May 19, 2005 Priority
Supplement 23 Manufacturing (CMC) Approved April 20, 2005 Priority
Supplement 21 Manufacturing (CMC) Approved January 18, 2005 Priority
Supplement 20 Manufacturing (CMC) Approved October 19, 2004 Priority
Supplement 19 Manufacturing (CMC) Approved August 12, 2004 Priority
Supplement 16 Labeling Approved June 24, 2004 Standard
Supplement 17 Manufacturing (CMC) Approved April 26, 2004 Priority
Supplement 18 Manufacturing (CMC) Approved April 24, 2004 Priority
Supplement 13 Manufacturing (CMC) Approved March 10, 2003 Priority
Supplement 15 Manufacturing (CMC) Approved February 28, 2003 Priority
Supplement 14 Efficacy Approved February 14, 2003 Priority
Supplement 12 Manufacturing (CMC) Approved May 7, 2002 Priority
Supplement 10 Labeling Approved April 26, 2002 Standard
Supplement 11 Manufacturing (CMC) Approved March 28, 2002 Priority
Supplement 9 Labeling Approved November 5, 2001 Standard
Supplement 8 Labeling Approved July 24, 2001 Standard
Supplement 6 Labeling Approved July 24, 2001 Standard
Supplement 5 Labeling Approved July 24, 2001 Priority
Supplement 7 Manufacturing (CMC) Approved July 13, 2001 Priority
Supplement 4 Manufacturing (CMC) Approved March 6, 2001 Priority

Review documents

  • 0 · Supplement · August 5, 2019
  • 0 · Supplement · August 5, 2019
  • 0 · Supplement · December 19, 2018
  • 0 · Supplement · December 19, 2018
  • 0 · Supplement · April 13, 2018
  • 0 · Supplement · April 6, 2018
  • 0 · Supplement · June 22, 2016
  • 0 · Supplement · June 21, 2016
  • 0 · Supplement · July 21, 2015
  • 0 · Supplement · July 20, 2015
  • 0 · Supplement · December 3, 2014
  • 0 · Supplement · November 28, 2014
  • 0 · Supplement · October 16, 2014
  • 0 · Supplement · October 15, 2014
  • 0 · Supplement · July 7, 2014
  • 0 · Supplement · June 3, 2014
  • 0 · Supplement · June 3, 2014
  • 0 · Supplement · August 12, 2013
  • Package Labeling · Supplement · August 12, 2013
  • 0 · Supplement · June 3, 2013
  • 0 · Supplement · June 3, 2013
  • 0 · Supplement · April 8, 2013
  • 0 · Supplement · January 29, 2013
  • 0 · Supplement · December 21, 2012
  • 0 · Supplement · December 21, 2012
  • 0 · Supplement · December 21, 2012
  • 0 · Supplement · August 20, 2012
  • 0 · Supplement · August 17, 2012
  • 0 · Supplement · March 24, 2011
  • 0 · Supplement · March 23, 2011

Adverse event reports

Source: openFDA FAERS
24,282
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: OSELTAMIVIR PHOSPHATE. 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
0004-0800-07 0004-0800 Genentech, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (0004-0800-07) / 10 CAPSULE in 1 BOTTLE, PLASTIC June 17, 2005
0004-0800-85 0004-0800 Genentech, Inc. 1 BLISTER PACK in 1 CARTON (0004-0800-85) / 10 CAPSULE in 1 BLISTER PACK October 27, 1999
0004-0802-85 0004-0802 Genentech, Inc. 1 BLISTER PACK in 1 CARTON (0004-0802-85) / 10 CAPSULE in 1 BLISTER PACK October 27, 1999
0004-0800 0004-0800 Genentech, Inc. — October 27, 1999
0004-0802 0004-0802 Genentech, Inc. — October 27, 1999

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.