Wednesday, July 8, 2026

Drug profile · INN

dextromethorphan hydrobromide

dextromethorphan hydrobromide (NUEDEXTA) is a glutamate [nmda] receptor subunit epsilon 1 antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: withdrawn Nervous system (N07) N07XX59
US status approved
Patents linked 16
Pipeline programs 1
News articles 0
Drug details — dextromethorphan hydrobromide
US status
approved
Class
Nervous system (N07)
Route
ORAL
Patents
16
Programs
1
Data quality
0.89

Quick answer

dextromethorphan hydrobromide (NUEDEXTA) is a glutamate [nmda] receptor subunit epsilon 1 antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN dextromethorphan hydrobromide
Brand NUEDEXTA
Mechanism Glutamate [NMDA] receptor subunit epsilon 1 antagonist
Target Glutamate receptor ionotropic, NMDA 2A
Therapeutic class Nervous system (N07)
Route ORAL
Formulation CAPSULE
ATC code N07XX59

Mechanism of action

Glutamate [NMDA] receptor subunit epsilon 1 antagonist

Primary target: Glutamate receptor ionotropic, NMDA 2A

Approval history

Authority Status Date
FDA approved
EMA withdrawn

Pipeline programs

  1. Dextromethorphan HBr Phase 1 · Kailera Therapeutics · Healthy

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)
  1. US 12357697

    Pharmaceutical compositions comprising bupropion and cysteine

    Expires Mon Jul 10 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12156914

    Pharmaceutical compositions comprising bupropion and cysteine

    Expires Mon Nov 28 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12077549

    Pentaaza macrocyclic ring complexes possessing oral bioavailability

    Expires Mon Aug 29 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11612608

    Methods of treating oral mucositis

    Expires Mon Mar 23 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11129826

    Bupropion as a modulator of drug activity

    Expires Mon Sep 23 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11123344

    Bupropion as a modulator of drug activity

    Expires Mon Sep 16 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11066433

    Pentaaza macrocyclic ring complexes possessing oral bioavailability

    Expires Mon Jul 15 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 10610533

    Methods of treating oral mucositis

    Expires Mon Apr 02 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 10597415

    Pentaaza macrocyclic ring complexes possessing oral bioavailability

    Expires Mon Mar 19 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 10350193

    Super-oxide dismutase mimetics

    Expires Mon Jul 11 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 9855279

    Methods of treating oral mucositis

    Expires Mon Dec 28 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 9738669

    Pentaaza macrocyclic ring complexes possessing oral bioavailability

    Expires Mon Aug 17 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 9738670

    Pentaaza macrocyclic ring complexes possessing oral bioavailability

    Expires Mon Aug 17 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 9642861

    Methods of treating oral mucositis

    Expires Mon May 04 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 9353069

    Super-oxide dismutase mimetics

    Expires Mon May 26 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 8486928

    Super-oxide dismutase mimetics

    Expires Mon Jul 11 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is dextromethorphan hydrobromide?

dextromethorphan hydrobromide (NUEDEXTA) is a glutamate [nmda] receptor subunit epsilon 1 antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for dextromethorphan hydrobromide?

NUEDEXTA is a marketed brand name for dextromethorphan hydrobromide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of dextromethorphan hydrobromide?

dextromethorphan hydrobromide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.