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Relistor

Methylnaltrexone bromide · Injection, Solution

Prescription NDA TE AP 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
Relistor
Generic name
Methylnaltrexone bromide
Dosage form
Injection, Solution
Route
Subcutaneous
Marketing category
NDA · NDA
Labeler
Salix Pharmaceuticals, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
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
Methylnaltrexone Bromide 12 mg/.6mL 979113 —
Methylnaltrexone Bromide 8 mg/.4mL 979113 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Subcutaneous
Presentations
6

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
Opioid Antagonist [EPC] EPC All 19 members
Opioid Antagonists [MoA] MoA All 19 members
Quaternary Ammonium Compounds [CS] CS 1 member — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021964
Application type
NDA · New Drug Application
Approval date
April 24, 2008
Sponsor
SALIX PHARMS
Products on application
3
Submissions recorded
13
Products approved under application 021964.
Product Trade name Form Strength Ingredient Status TE Flags
021964-001 RELISTOR SOLUTION METHYLNALTREXONE BROMIDE Prescription AP RLD RS
021964-002 RELISTOR SOLUTION METHYLNALTREXONE BROMIDE Prescription AP RLD RS
021964-003 RELISTOR SOLUTION METHYLNALTREXONE BROMIDE Prescription AP RLD RS

Therapeutic equivalence

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

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)

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

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
12303592 August 3, 2027 001 No U-4197 June 12, 2025
12303592 August 3, 2027 001 No U-4198 June 12, 2025
12303592 August 3, 2027 002 No U-4197 June 12, 2025
12303592 August 3, 2027 002 No U-4198 June 12, 2025
12303592 August 3, 2027 003 No U-4197 June 12, 2025
12303592 August 3, 2027 003 No U-4198 June 12, 2025
8420663 September 30, 2029 001 No U-1185 April 24, 2013
9180125 September 30, 2029 001 No U-1185 November 20, 2015
8822490 September 30, 2029 001 No U-1185 September 22, 2014
9492445 September 30, 2029 001 No U-1185 August 30, 2017
8420663 September 30, 2029 002 No U-1185 —
8822490 September 30, 2029 002 No U-1185 September 22, 2014
9180125 September 30, 2029 002 No U-1185 November 20, 2015
9492445 September 30, 2029 002 No U-1185 August 30, 2017
8420663 September 30, 2029 003 No U-1185 —
8822490 September 30, 2029 003 No U-1185 September 22, 2014
9180125 September 30, 2029 003 No U-1185 November 20, 2015
9492445 September 30, 2029 003 No U-1185 August 30, 2017
8247425 December 31, 2030 001 No U-1185 September 13, 2012
8247425 December 31, 2030 002 No U-1185 —
8247425 December 31, 2030 003 No U-1185 —

Approval history

Source: Drugs@FDA
Most recent submissions on application 021964.
Type No. Action Status Date Review
Supplement 19 Labeling Approved March 14, 2018 Standard
Supplement 18 Labeling Approved August 1, 2017 Standard
Supplement 17 Labeling Approved May 16, 2017 Standard
Supplement 16 Manufacturing (CMC) Approved February 5, 2016 Standard
Supplement 12 Manufacturing (CMC) Approved April 30, 2015 Standard
Supplement 15 Manufacturing (CMC) Approved February 9, 2015 Standard
Supplement 10 Efficacy Approved September 29, 2014 Standard
Supplement 14 Manufacturing (CMC) Approved December 20, 2013 Standard
Supplement 11 Labeling Approved August 23, 2013 Standard
Supplement 8 Labeling Approved September 27, 2010 Unknown
Supplement 9 Labeling Approved July 23, 2010 Unknown
Supplement 6 Labeling Approved November 4, 2009 Standard
Original application 1 Type 1 - New Molecular Entity Approved April 24, 2008 Standard

Review documents

  • 0 · Supplement · February 24, 2021
  • 0 · Supplement · March 15, 2018
  • 0 · Supplement · March 15, 2018
  • 0 · Supplement · August 29, 2017
  • 0 · Supplement · August 3, 2017
  • 0 · Supplement · May 19, 2017
  • 0 · Supplement · May 18, 2017
  • 0 · Supplement · October 2, 2014
  • 0 · Supplement · September 30, 2014
  • 0 · Supplement · August 27, 2013
  • 0 · Supplement · August 27, 2013
  • 0 · Supplement · July 30, 2010
  • 0 · Supplement · July 28, 2010
  • 0 · Supplement · January 21, 2010
  • 0 · Supplement · November 23, 2009
  • 0 · Original application · June 3, 2008
  • 0 · Original application · April 28, 2008

Adverse event reports

Source: openFDA FAERS
1,497
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: METHYLNALTREXONE BROMIDE. 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
65649-551-02 65649-551 Salix Pharmaceuticals, Inc. 1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE April 24, 2008
65649-551-03 65649-551 Salix Pharmaceuticals, Inc. 7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE April 24, 2008
65649-551-07 65649-551 Salix Pharmaceuticals, Inc. 1 BLISTER PACK in 1 CARTON (65649-551-07) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE April 24, 2008
65649-552-04 65649-552 Salix Pharmaceuticals, Inc. 7 BLISTER PACK in 1 CARTON (65649-552-04) / 1 SYRINGE in 1 BLISTER PACK / .4 mL in 1 SYRINGE April 24, 2008
65649-551 65649-551 Salix Pharmaceuticals, Inc. — April 24, 2008
65649-552 65649-552 Salix Pharmaceuticals, Inc. — April 24, 2008

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 · 11 sections on this page.