NDC 63739-466

Nalbuphine Hydrochloride

Nalbuphine Hydrochloride

Nalbuphine Hydrochloride is a Intramuscular; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mckesson Corporation. The primary component is Nalbuphine Hydrochloride.

• Product ID: 63739-466_95d7636a-3349-440a-ac33-e37e4439009d
• NDC: 63739-466
• Product Type: Human Prescription Drug
• Proprietary Name: Nalbuphine Hydrochloride
• Generic Name: Nalbuphine Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2008-06-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA070916
• Labeler Name: McKesson Corporation
• Substance Name: NALBUPHINE HYDROCHLORIDE
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63739-466-05

5 AMPULE in 1 BOX (63739-466-05) > 1 mL in 1 AMPULE

• Marketing Start Date: 2004-12-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63739-466-21 [63739046621]

Nalbuphine Hydrochloride INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA070916
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2004-12-31
• Marketing End Date: 2020-02-24

NDC 63739-466-05 [63739046605]

Nalbuphine Hydrochloride INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA070916
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2004-12-31
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-25

Drug Details

Active Ingredients

Ingredient	Strength
NALBUPHINE HYDROCHLORIDE	20 mg/mL

OpenFDA Data

• SPL SET ID: ee8fe2ea-a6c7-485e-bea9-1b94ff66b05c
• Manufacturer:
  • McKesson Corporation
• UNII:
  • ZU4275277R
• RxNorm Concept Unique ID - RxCUI:
  • 1866551

Pharmacological Class

• Competitive Opioid Antagonists [MoA]
• Opioid Agonist/Antagonist [EPC]
• Partial Opioid Agonists [MoA]

NDC Crossover Matching brand name "Nalbuphine Hydrochloride" or generic name "Nalbuphine Hydrochloride"

NDC	Brand Name	Generic Name
0404-9917	Nalbuphine Hydrochloride	nalbuphine hydrochloride
0404-9918	Nalbuphine Hydrochloride	Nalbuphine Hydrochloride
0404-9919	Nalbuphine Hydrochloride	nalbuphine hydrochloride
0409-1463	Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE
0409-1464	Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE
0409-1465	Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE
0409-1467	Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE
52584-083	Nalbuphine Hydrochloride	nalbuphine hydrochloride
52584-463	Nalbuphine Hydrochloride	Nalbuphine Hydrochloride
52584-464	Nalbuphine Hydrochloride	nalbuphine hydrochloride
63739-466	Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE
71872-7114	Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE