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REMERON

Mirtazapine · 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
REMERON
Generic name
Mirtazapine
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Organon LLC
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
Mirtazapine 15 mg/1 314111 View
Mirtazapine 30 mg/1 314111 View

Forms, strengths and routes

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

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020415
Application type
NDA · New Drug Application
Approval date
June 14, 1996
Sponsor
ORGANON
Products on application
3
Submissions recorded
31
Products approved under application 020415.
Product Trade name Form Strength Ingredient Status TE Flags
020415-001 REMERON TABLET MIRTAZAPINE Prescription AB RLD RS
020415-002 REMERON TABLET MIRTAZAPINE Prescription AB RLD
020415-003 REMERON TABLET MIRTAZAPINE Discontinued — 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 020415.
Type No. Action Status Date Review
Supplement 39 Manufacturing (CMC) Approved July 23, 2025 Standard
Supplement 38 Labeling Approved November 18, 2021 Standard
Supplement 36 Labeling Approved April 29, 2020 Standard
Supplement 34 Labeling Approved April 29, 2020 Standard
Supplement 29 Labeling Approved March 4, 2020 Standard
Supplement 35 Labeling Approved September 5, 2019 Standard
Supplement 30 Labeling Approved July 8, 2016 Standard
Supplement 32 Labeling Approved December 30, 2015 Standard
Supplement 28 Manufacturing (CMC) Approved September 30, 2014 Standard
Supplement 31 Labeling Approved July 18, 2014 901 Required
Supplement 27 Manufacturing (CMC) Approved December 11, 2012 Standard
Supplement 26 Labeling Approved October 30, 2012 Standard
Supplement 22 Labeling Approved December 27, 2011 Standard
Supplement 24 Labeling Approved May 14, 2010 Unknown
Supplement 23 Labeling Approved May 14, 2010 Unknown
Supplement 19 Labeling Approved July 30, 2007 Standard
Supplement 18 Labeling Approved January 12, 2005 Standard
Supplement 16 Labeling Approved June 1, 2004 Standard
Supplement 15 Labeling Approved September 30, 2002 Standard
Supplement 9 Efficacy Approved April 9, 2002 Standard
Supplement 14 Manufacturing (CMC) Approved November 20, 2001 Standard
Supplement 10 Manufacturing (CMC) Approved January 26, 2001 Standard
Supplement 6 Labeling Approved August 30, 2000 Standard
Supplement 8 Manufacturing (CMC) Approved July 19, 2000 Standard
Supplement 7 Labeling Approved February 28, 2000 Standard
Supplement 5 Manufacturing (CMC) Approved May 11, 1999 Standard
Supplement 4 Manufacturing (CMC) Approved April 9, 1998 Standard
Supplement 3 Manufacturing (CMC) Approved March 17, 1997 Standard
Supplement 2 Manufacturing (CMC) Approved November 7, 1996 Standard
Supplement 1 Manufacturing (CMC) Approved November 4, 1996 Standard
Original application 1 Type 1 - New Molecular Entity Approved June 14, 1996 Standard

Review documents

  • 0 · Supplement · May 21, 2026
  • 0 · Supplement · May 21, 2026
  • 0 · Supplement · November 19, 2021
  • 0 · Supplement · November 19, 2021
  • 0 · Supplement · April 30, 2020
  • 0 · Supplement · April 30, 2020
  • 0 · Supplement · April 30, 2020
  • 0 · Supplement · April 30, 2020
  • 0 · Supplement · March 4, 2020
  • 0 · Supplement · March 4, 2020
  • 0 · Supplement · September 6, 2019
  • 0 · Supplement · September 6, 2019
  • 0 · Supplement · August 1, 2016
  • 0 · Supplement · December 31, 2015
  • 0 · Supplement · December 31, 2015
  • 0 · Supplement · July 30, 2014
  • 0 · Supplement · July 23, 2014
  • 0 · Supplement · November 6, 2012
  • 0 · Supplement · November 1, 2012
  • 0 · Supplement · December 29, 2011
  • 0 · Supplement · December 27, 2011
  • 0 · Supplement · May 28, 2010
  • 0 · Supplement · May 28, 2010
  • 0 · Supplement · May 21, 2010
  • 0 · Supplement · May 21, 2010
  • 0 · Supplement · August 2, 2007
  • 0 · Supplement · July 31, 2007
  • 0 · Original application · August 1, 2005
  • 0 · Supplement · January 13, 2005
  • 0 · Supplement · January 13, 2005

Adverse event reports

Source: openFDA FAERS
91,059
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: MIRTAZAPINE. 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
78206-160-01 78206-160 Organon LLC 30 TABLET, FILM COATED in 1 BOTTLE (78206-160-01) June 1, 2021
78206-161-01 78206-161 Organon LLC 30 TABLET, FILM COATED in 1 BOTTLE (78206-161-01) June 1, 2021
78206-160 78206-160 Organon LLC — June 1, 2021
78206-161 78206-161 Organon LLC — June 1, 2021

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 · 9 sections on this page.