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NDC 00409-1463-01 Nalbuphine Hydrochloride 10 mg/mL Details

Nalbuphine Hydrochloride 10 mg/mL

Nalbuphine Hydrochloride is a INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hospira, Inc.. The primary component is NALBUPHINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Nalbuphine injection is used is used to relieve moderate to severe pain. It is also used with other medications and anesthesic agents before, during, and after surgery and other medical procedures. Nalbuphine injection is in a class of medications called opioid agonist-antagonists. It works by changing the way the body senses pain.

Related Packages: 00409-1463-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nalbuphine Injection

Product Information

NDC	00409-1463
Product ID	0409-1463_c6be438f-eb10-48bd-bcdb-2b58569850b8
Associated GPIs	65200030102005
GCN Sequence Number	004229
GCN Sequence Number Description	nalbuphine HCl AMPUL 10 MG/ML INJECTION
HIC3	H3A
HIC3 Description	OPIOID ANALGESICS
GCN	16360
HICL Sequence Number	001744
HICL Sequence Number Description	NALBUPHINE HCL
Brand/Generic	Generic
Proprietary Name	Nalbuphine Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	NALBUPHINE HYDROCHLORIDE
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	INJECTION, SOLUTION
Route	INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	NALBUPHINE HYDROCHLORIDE
Labeler Name	Hospira, Inc.
Pharmaceutical Class	Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA070914
Listing Certified Through	2024-12-31

Package

NDC 00409-1463-01 (00409146301)

Pricing Information	N/A
NDC Package Code	0409-1463-01
Billing NDC	00409146301
Package	10 AMPULE in 1 TRAY (0409-1463-01) / 1 mL in 1 AMPULE (0409-1463-71)
Marketing Start Date	2005-03-31
NDC Exclude Flag	N