Wednesday, July 8, 2026

Drug profile · INN

hydrocodone bitartrate

hydrocodone bitartrate (HYDROCODONE BITARTRATE) is a opioid receptors; mu/kappa/delta agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 6
Pipeline programs 9
News articles 0
Drug details — hydrocodone bitartrate
US status
approved
Class
Route
ORAL
Patents
6
Programs
9
Data quality
0.89

Quick answer

hydrocodone bitartrate (HYDROCODONE BITARTRATE) is a opioid receptors; mu/kappa/delta agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN hydrocodone bitartrate
Brand HYDROCODONE BITARTRATE
Mechanism Opioid receptors; mu/kappa/delta agonist
Target Opioid receptors; mu/kappa/delta
Route ORAL
Formulation TABLET, EXTENDED RELEASE

Mechanism of action

Opioid receptors; mu/kappa/delta agonist

Primary target: Opioid receptors; mu/kappa/delta

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. EPREX® Phase 3 · Sunshine Guojian Pharmaceutical · Renal Anemia
  2. Hydrocodone ER Phase 3 · Teva Pharma · Low Back Pain
  3. Hydrocodone ER Phase 3 · Teva Pharma · Chronic Pain
  4. 45-mg hydrocodone bitartrate extended-release tablet (crushed or intact) Phase 1 · Teva Pharma · Drug Abuse
  5. C33237/1099 Phase 1 · Teva Pharma · Pain
  6. C33237/1106 Phase 1 · Teva Pharma · Pain
  7. Hydrocodone Bitartrate Phase 1 · BRIGHT MINDS BIOSCIENCES · Healthy
  8. Hydrocodone Bitartrate extended-release tablet Phase 1 · Teva Pharma · Renal Impairment

Related & competitor drugs

  1. codeine phosphate Opioid receptors; mu/kappa/delta agonist
  2. naloxone hydrochloride Opioid receptors; mu/kappa/delta antagonist
  3. naltrexone Alimentary tract and metabolism (A08)
  4. naltrexone hydrochloride Opioid receptors; mu/kappa/delta antagonist
  5. oxymorphone hydrochloride Opioid receptors; mu/kappa/delta agonist
  6. codeine sulfate Opioid receptors; mu/kappa/delta agonist
  1. US 10092559

    Abuse resistant pharmaceutical compositions

    Expires Mon Oct 04 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10028946

    Treating pain in patients with hepatic impairment

    Expires Mon Jul 19 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 9713611

    Abuse resistant pharmaceutical compositions

    Expires Mon Jul 20 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 9486451

    Abuse resistant pharmaceutical compositions

    Expires Mon Nov 03 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 9452163

    Abuse resistant pharmaceutical compositions

    Expires Mon Sep 22 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 9132096

    Abuse resistant pharmaceutical compositions

    Expires Mon Sep 10 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is hydrocodone bitartrate?

hydrocodone bitartrate (HYDROCODONE BITARTRATE) is a opioid receptors; mu/kappa/delta agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for hydrocodone bitartrate?

HYDROCODONE BITARTRATE is a marketed brand name for hydrocodone bitartrate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of hydrocodone bitartrate?

hydrocodone bitartrate 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.