nalbuphine hci

Generic: nalbuphine hci

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nalbuphine hci
Generic Name nalbuphine hci
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

nalbuphine hydrochloride 10 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1420
Product ID 51662-1420_2b37c789-d5da-dc83-e063-6294a90a4ca5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070915
Listing Expiration 2026-12-31
Marketing Start 2019-10-29

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 516621420
Hyphenated Format 51662-1420

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 hci (source: ndc)
Generic Name nalbuphine hci (source: ndc)
Application Number ANDA070915 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (51662-1420-1) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

51662-1420-1 1 VIAL, MULTI-DOSE in 1 CARTON (51662-1420-1) / 10 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

nalbuphine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

NALBUPHINE HCI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "2b37c789-d5da-dc83-e063-6294a90a4ca5", "openfda": {"unii": ["ZU4275277R"], "rxcui": ["904415"], "spl_set_id": ["96139914-0708-7b58-e053-2995a90a7308"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (51662-1420-1)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "51662-1420-1", "marketing_start_date": "20191029"}], "brand_name": "NALBUPHINE HCI", "product_id": "51662-1420_2b37c789-d5da-dc83-e063-6294a90a4ca5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Competitive Opioid Antagonists [MoA]", "Opioid Agonist/Antagonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "51662-1420", "generic_name": "NALBUPHINE HCI", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NALBUPHINE HCI", "active_ingredients": [{"name": "NALBUPHINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA070915", "marketing_category": "ANDA", "marketing_start_date": "20191029", "listing_expiration_date": "20261231"}