nalbuphine hydrochloride

Generic: nalbuphine hydrochloride

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nalbuphine hydrochloride
Generic Name nalbuphine hydrochloride
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

nalbuphine hydrochloride 10 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-1463
Product ID 0409-1463_0bef11ef-0544-4717-9f45-e4909cc86cc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070914
Listing Expiration 2026-12-31
Marketing Start 2008-06-27

Pharmacologic Class

Classes
competitive opioid antagonists [moa] opioid agonist/antagonist [epc] partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04091463
Hyphenated Format 0409-1463

Supplemental Identifiers

RxCUI
1866543
UNII
ZU4275277R

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nalbuphine hydrochloride (source: ndc)
Generic Name nalbuphine hydrochloride (source: ndc)
Application Number ANDA070914 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 TRAY (0409-1463-49) / 1 mL in 1 AMPULE (0409-1463-69)
source: ndc

Packages (1)

0409-1463-49 10 AMPULE in 1 TRAY (0409-1463-49) / 1 mL in 1 AMPULE (0409-1463-69)

Ingredients (1)

nalbuphine hydrochloride (10 mg/mL)

Linked Drug Pages (2)

Nalbuphine Hydrochloride ndc-match (0.9) Nalbuphine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "0bef11ef-0544-4717-9f45-e4909cc86cc0", "openfda": {"unii": ["ZU4275277R"], "rxcui": ["1866543"], "spl_set_id": ["a99fe500-f52b-483c-807c-178f1a78a02b"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 TRAY (0409-1463-49)  / 1 mL in 1 AMPULE (0409-1463-69)", "package_ndc": "0409-1463-49", "marketing_start_date": "20080627"}], "brand_name": "Nalbuphine Hydrochloride", "product_id": "0409-1463_0bef11ef-0544-4717-9f45-e4909cc86cc0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Competitive Opioid Antagonists [MoA]", "Opioid Agonist/Antagonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0409-1463", "generic_name": "NALBUPHINE HYDROCHLORIDE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nalbuphine Hydrochloride", "active_ingredients": [{"name": "NALBUPHINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA070914", "marketing_category": "ANDA", "marketing_start_date": "20080627", "listing_expiration_date": "20261231"}