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United States · US · US:59011-960_5c39d4d2-5cb7-4840-b695-6b162e575301

NALMEFENE HYDROCHLORIDE

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
    5901196010
    10 VIAL, GLASS in 1 CARTON (59011-960-10) / 2 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
K7K69QC05X
NALMEFENE HYDROCHLORIDE
RxCUI 236069
Orange Book
A212955
AP
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; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7": {
      "match": "brand_token",
      "title": "NALMEFENE HYDROCHLORIDE INJECTION, SOLUTION [KNOA PHARMA LLC]",
      "spl_version": "7",
      "published_date": "2026-05-06"
    }
  },
  "productid": "59011-960_5c39d4d2-5cb7-4840-b695-6b162e575301",
  "productndc": "59011-960",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212955",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2MG BASE/2ML (EQ 1MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Feb 8, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NALMEFENE HYDROCHLORIDE",
  "proprietary_name": "NALMEFENE HYDROCHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA212955",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NALMEFENE HYDROCHLORIDE",
  "start_marketing_date": "20220208",
  "active_numerator_strength": "1"
}

Related drugs

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