nalbuphine hydrochloride

Generic: nalbuphine hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nalbuphine hydrochloride
Generic Name nalbuphine hydrochloride
Labeler somerset therapeutics, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

nalbuphine hydrochloride 10 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-671
Product ID 70069-671_d7e3d7be-ce38-4696-979c-64dd1023a4cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216050
Listing Expiration 2026-12-31
Marketing Start 2024-09-25

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 70069671
Hyphenated Format 70069-671

Supplemental Identifiers

RxCUI
1866543 1866551
UPC
0370069671108 0370069671016 0370069672013 0370069672105
UNII
ZU4275277R

Packaging Origin

Original Packager
true

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 ANDA216050 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 CARTON (70069-671-10) / 1 mL in 1 AMPULE (70069-671-01)
source: ndc

Packages (1)

70069-671-10 10 AMPULE in 1 CARTON (70069-671-10) / 1 mL in 1 AMPULE (70069-671-01)

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": "d7e3d7be-ce38-4696-979c-64dd1023a4cd", "openfda": {"upc": ["0370069671108", "0370069671016", "0370069672013", "0370069672105"], "unii": ["ZU4275277R"], "rxcui": ["1866543", "1866551"], "spl_set_id": ["a3221c05-5822-4ab8-b589-0e3939b91a68"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 CARTON (70069-671-10)  / 1 mL in 1 AMPULE (70069-671-01)", "package_ndc": "70069-671-10", "marketing_start_date": "20240925"}], "brand_name": "Nalbuphine hydrochloride", "product_id": "70069-671_d7e3d7be-ce38-4696-979c-64dd1023a4cd", "dosage_form": "INJECTION", "pharm_class": ["Competitive Opioid Antagonists [MoA]", "Opioid Agonist/Antagonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "70069-671", "generic_name": "Nalbuphine hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nalbuphine hydrochloride", "active_ingredients": [{"name": "NALBUPHINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA216050", "marketing_category": "ANDA", "marketing_start_date": "20240925", "listing_expiration_date": "20261231"}