nalbuphine hydrochloride

Generic: nalbuphine hydrochloride

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nalbuphine hydrochloride
Generic Name nalbuphine hydrochloride
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

nalbuphine hydrochloride 10 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-464
Product ID 84549-464_463cff7e-0486-7c6d-e063-6294a90ae0e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070915
Listing Expiration 2026-12-31
Marketing Start 2005-07-19

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 84549464
Hyphenated Format 84549-464

Supplemental Identifiers

RxCUI
904415
UNII
ZU4275277R

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 ANDA070915 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, MULTI-DOSE (84549-464-01)
source: ndc

Packages (1)

84549-464-01 10 mL in 1 VIAL, MULTI-DOSE (84549-464-01)

Ingredients (1)

nalbuphine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Nalbuphine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "463cff7e-0486-7c6d-e063-6294a90ae0e7", "openfda": {"unii": ["ZU4275277R"], "rxcui": ["904415"], "spl_set_id": ["38569b5f-fb37-135e-e063-6294a90a54df"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, MULTI-DOSE (84549-464-01)", "package_ndc": "84549-464-01", "marketing_start_date": "20250827"}], "brand_name": "Nalbuphine Hydrochloride", "product_id": "84549-464_463cff7e-0486-7c6d-e063-6294a90ae0e7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Competitive Opioid Antagonists [MoA]", "Opioid Agonist/Antagonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "84549-464", "generic_name": "NALBUPHINE HYDROCHLORIDE", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nalbuphine Hydrochloride", "active_ingredients": [{"name": "NALBUPHINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA070915", "marketing_category": "ANDA", "marketing_start_date": "20050719", "listing_expiration_date": "20261231"}