nalbuphine hydrochloride

Generic: nalbuphine hydrochloride

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

Drug Facts

Product Profile

Brand Name nalbuphine hydrochloride
Generic Name nalbuphine hydrochloride
Labeler henry schein, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCONJUNCTIVAL
Active Ingredients

nalbuphine hydrochloride 10 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9767
Product ID 0404-9767_f07091d0-6f67-4cd7-8fae-3cce4b3385af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216049
Listing Expiration 2026-12-31
Marketing Start 2025-12-11

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 04049767
Hyphenated Format 0404-9767

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 ANDA216049 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCONJUNCTIVAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 BAG (0404-9767-10) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0404-9767-10 1 VIAL, MULTI-DOSE in 1 BAG (0404-9767-10) / 10 mL in 1 VIAL, MULTI-DOSE

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", "SUBCONJUNCTIVAL"], "spl_id": "f07091d0-6f67-4cd7-8fae-3cce4b3385af", "openfda": {"unii": ["ZU4275277R"], "rxcui": ["904415"], "spl_set_id": ["4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2d"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9767-10)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0404-9767-10", "marketing_start_date": "20251211"}], "brand_name": "Nalbuphine Hydrochloride", "product_id": "0404-9767_f07091d0-6f67-4cd7-8fae-3cce4b3385af", "dosage_form": "INJECTION", "pharm_class": ["Competitive Opioid Antagonists [MoA]", "Opioid Agonist/Antagonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0404-9767", "generic_name": "nalbuphine hydrochloride", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nalbuphine Hydrochloride", "active_ingredients": [{"name": "NALBUPHINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA216049", "marketing_category": "ANDA", "marketing_start_date": "20251211", "listing_expiration_date": "20261231"}