nalmefene hydrochloride

Generic: nalmefene hydrochloride

Labeler: purdue pharma l.p.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nalmefene hydrochloride
Generic Name nalmefene hydrochloride
Labeler purdue pharma l.p.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

nalmefene hydrochloride 1 mg/mL

Manufacturer
Purdue Pharma L.P.

Identifiers & Regulatory

Product NDC 59011-960
Product ID 59011-960_ec96ac7c-4d1f-4973-b7de-a7955acbd557
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212955
Listing Expiration 2026-12-31
Marketing Start 2022-02-08

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59011960
Hyphenated Format 59011-960

Supplemental Identifiers

RxCUI
2592953
UNII
K7K69QC05X

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 nalmefene hydrochloride (source: ndc)
Generic Name nalmefene hydrochloride (source: ndc)
Application Number ANDA212955 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (59011-960-10) / 2 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

59011-960-10 10 VIAL, GLASS in 1 CARTON (59011-960-10) / 2 mL in 1 VIAL, GLASS

Ingredients (1)

nalmefene hydrochloride (1 mg/mL)

Linked Drug Pages (1)

NALMEFENE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "ec96ac7c-4d1f-4973-b7de-a7955acbd557", "openfda": {"unii": ["K7K69QC05X"], "rxcui": ["2592953"], "spl_set_id": ["3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7"], "manufacturer_name": ["Purdue Pharma L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (59011-960-10)  / 2 mL in 1 VIAL, GLASS", "package_ndc": "59011-960-10", "marketing_start_date": "20220208"}], "brand_name": "NALMEFENE HYDROCHLORIDE", "product_id": "59011-960_ec96ac7c-4d1f-4973-b7de-a7955acbd557", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "59011-960", "generic_name": "NALMEFENE HYDROCHLORIDE", "labeler_name": "Purdue Pharma L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NALMEFENE HYDROCHLORIDE", "active_ingredients": [{"name": "NALMEFENE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA212955", "marketing_category": "ANDA", "marketing_start_date": "20220208", "listing_expiration_date": "20261231"}