Package 84549-464-01
Brand: nalbuphine hydrochloride
Generic: nalbuphine hydrochloridePackage Facts
Identity
Package NDC
84549-464-01
Digits Only
8454946401
Product NDC
84549-464
Description
10 mL in 1 VIAL, MULTI-DOSE (84549-464-01)
Marketing
Marketing Status
Brand
nalbuphine hydrochloride
Generic
nalbuphine hydrochloride
Sample Package
No
Linked Drug Pages (1)
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"}