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, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

nalbuphine hydrochloride 10 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9918
Product ID 0404-9918_0e0e0bdd-27ee-48e6-9390-56ec6e71eccc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070914
Listing Expiration 2026-12-31
Marketing Start 2022-01-13

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 04049918
Hyphenated Format 0404-9918

Supplemental Identifiers

RxCUI
1866543
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 ANDA070914 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 AMPULE in 1 BAG (0404-9918-01) / 1 mL in 1 AMPULE
source: ndc

Packages (1)

0404-9918-01 1 AMPULE in 1 BAG (0404-9918-01) / 1 mL in 1 AMPULE

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": "0e0e0bdd-27ee-48e6-9390-56ec6e71eccc", "openfda": {"unii": ["ZU4275277R"], "rxcui": ["1866543"], "spl_set_id": ["596826ff-e471-4d4f-9a73-2a34e2af2dd6"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 AMPULE in 1 BAG (0404-9918-01)  / 1 mL in 1 AMPULE", "package_ndc": "0404-9918-01", "marketing_start_date": "20220113"}], "brand_name": "Nalbuphine Hydrochloride", "product_id": "0404-9918_0e0e0bdd-27ee-48e6-9390-56ec6e71eccc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Competitive Opioid Antagonists [MoA]", "Opioid Agonist/Antagonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0404-9918", "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": "ANDA070914", "marketing_category": "ANDA", "marketing_start_date": "20220113", "listing_expiration_date": "20261231"}