zurnai

Generic: nalmefene hydrochloride

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

Drug Facts

Product Profile

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

nalmefene hydrochloride 1.5 mg/.5mL

Manufacturer
Purdue Pharma L.P.

Identifiers & Regulatory

Product NDC 59011-962
Product ID 59011-962_85f9bafe-cf03-46b7-940a-248747e77bd2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218590
Listing Expiration 2027-12-31
Marketing Start 2025-08-07

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59011962
Hyphenated Format 59011-962

Supplemental Identifiers

RxCUI
2720806 2720812
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 zurnai (source: ndc)
Generic Name nalmefene hydrochloride (source: ndc)
Application Number NDA218590 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/.5mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (59011-962-01) / .5 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

59011-962-01 1 SYRINGE, GLASS in 1 CARTON (59011-962-01) / .5 mL in 1 SYRINGE, GLASS

Ingredients (1)

nalmefene hydrochloride (1.5 mg/.5mL)

Linked Drug Pages (1)

Zurnai ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "SUBCUTANEOUS"], "spl_id": "85f9bafe-cf03-46b7-940a-248747e77bd2", "openfda": {"unii": ["K7K69QC05X"], "rxcui": ["2720806", "2720812"], "spl_set_id": ["a59a5847-9fe4-4341-a203-be0a5e6d3e36"], "manufacturer_name": ["Purdue Pharma L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (59011-962-01)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "59011-962-01", "marketing_start_date": "20250807"}], "brand_name": "Zurnai", "product_id": "59011-962_85f9bafe-cf03-46b7-940a-248747e77bd2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "59011-962", "generic_name": "NALMEFENE HYDROCHLORIDE", "labeler_name": "Purdue Pharma L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zurnai", "active_ingredients": [{"name": "NALMEFENE HYDROCHLORIDE", "strength": "1.5 mg/.5mL"}], "application_number": "NDA218590", "marketing_category": "NDA", "marketing_start_date": "20250807", "listing_expiration_date": "20271231"}