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United States · US · US:59011-962_34c86c07-3873-4f16-ac8d-8284c68426c3

Zurnai

Orange BookUNIISPLATC N07BB05

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerKnoa Pharma LLC
CountryUS (United States)
ATC codeN07BB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5901196201
    1 SYRINGE, GLASS in 1 CARTON (59011-962-01) / .5 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)
K7K69QC05X
NALMEFENE HYDROCHLORIDE
RxCUI 236069
Orange Book
N218590
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "K7K69QC05X",
    "rxcui": "236069",
    "inchikey": "GYWMRGWFQPSQLK-OPHZJPRHSA-N",
    "display_name": "NALMEFENE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; SUBCUTANEOUS",
  "spl_meta": {
    "a59a5847-9fe4-4341-a203-be0a5e6d3e36": {
      "match": "brand_token",
      "title": "ZURNAI (NALMEFENE HYDROCHLORIDE) INJECTION, SOLUTION [KNOA PHARMA LLC ]",
      "spl_version": "7",
      "published_date": "2026-05-13"
    }
  },
  "productid": "59011-962_34c86c07-3873-4f16-ac8d-8284c68426c3",
  "productndc": "59011-962",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "218590",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)",
        "product_no": "001",
        "approval_date": "Aug 7, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NALMEFENE HYDROCHLORIDE",
  "proprietary_name": "Zurnai",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA218590",
  "marketing_category": "NDA",
  "nonproprietary_name": "NALMEFENE HYDROCHLORIDE",
  "start_marketing_date": "20250807",
  "active_numerator_strength": "1.5"
}

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