MedPath

Nalbuphine

Generic Name
Nalbuphine
Drug Type
Small Molecule
Chemical Formula
C21H27NO4
CAS Number
20594-83-6
Unique Ingredient Identifier
L2T84IQI2K

Overview

A narcotic used as a pain medication. It appears to be an agonist at kappa opioid receptors and an antagonist or partial agonist at mu opioid receptors. Nalbuphine is the only opioid analgesic that is not a controlled substance in the United States.

Background

A narcotic used as a pain medication. It appears to be an agonist at kappa opioid receptors and an antagonist or partial agonist at mu opioid receptors. Nalbuphine is the only opioid analgesic that is not a controlled substance in the United States.

Indication

For the relief of moderate to severe pain.

Associated Conditions

  • Severe Pain
  • Moderate Pain
  • Obstetrical analgesia therapy

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/25
Phase 1
Recruiting
2025/06/11
Phase 1
Not yet recruiting
2025/05/30
Phase 2
Not yet recruiting
Dr. Asma Abdus Salam
2024/12/16
Phase 4
Not yet recruiting
2024/12/09
Phase 4
Not yet recruiting
2024/12/06
Phase 4
Not yet recruiting
2024/10/09
Phase 2
Recruiting
2024/09/13
Not Applicable
Completed
Muhammad Aamir Latif
2024/07/08
Phase 4
Not yet recruiting
Kasr El Aini Hospital
2024/06/26
Not Applicable
Completed
Atif Shafqat

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Hospira, Inc.
0409-1463
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
10 mg in 1 mL
12/1/2022
Hospira, Inc.
0409-1465
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
20 mg in 1 mL
12/1/2022
Somerset Therapeutics, LLC
70069-671
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
10 mg in 1 mL
3/26/2025
Hospira, Inc.
0409-1467
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
20 mg in 1 mL
12/1/2022
Medical Purchasing Solutions, LLC
71872-7114
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
10 mg in 1 mL
5/23/2023
Henry Schein, Inc.
0404-9917
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
20 mg in 1 mL
11/10/2023
Hospira, Inc.
0409-1463
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
10 mg in 1 mL
12/1/2022
Hospira, Inc.
0409-1464
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
10 mg in 1 mL
12/1/2022
Somerset Therapeutics, LLC
70069-672
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
20 mg in 1 mL
3/26/2025
HF Acquisition Co LLC, DBA HealthFirst
51662-1418
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
20 mg in 1 mL
2/22/2020

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Nalbuphine Hydrochloride Injection
国药准字H20213884
化学药品
注射剂
11/24/2021
Nalbuphine Hydrochloride Injection
国药准字H20130127
化学药品
注射剂
8/11/2023
Nalbuphine Hydrochloride Injection
国药准字H20227102
化学药品
注射剂
8/11/2023
Nalbuphine Hydrochloride Injection
国药准字H20213459
化学药品
注射剂
6/8/2021
Nalbuphine Hydrochloride Injection
国药准字H20243242
化学药品
注射剂
2/23/2024
Nalbuphine Hydrochloride Injection
国药准字H20243241
化学药品
注射剂
2/23/2024
Nalbuphine Hydrochloride Injection
国药准字H20223205
化学药品
注射剂
4/8/2022
Nalbuphine Hydrochloride Injection
国药准字H20237124
化学药品
注射剂
10/23/2023

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
© Copyright 2025. All Rights Reserved by MedPath