nalmefene hydrochloride

Orange BookUNIISPLATC N07BB05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerChengdu Shuode Pharmaceutical Co., Ltd

CountryUS (United States)

ATC codeN07BB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8243210202
1 VIAL, GLASS in 1 CARTON (82432-102-02) / 2 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

K7K69QC05X

NALMEFENE HYDROCHLORIDE

RxCUI 236069

Orange Book

A216007

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": "82432-102_52b8bd13-33cb-4def-a172-8853a39fe4c4",
  "productndc": "82432-102",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "216007",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Nov 15, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2MG BASE/2ML (EQ 1MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Nov 15, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NALMEFENE HYDROCHLORIDE",
  "proprietary_name": "nalmefene hydrochloride",
  "active_ingred_unit": "mg/2mL",
  "application_number": "ANDA216007",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nalmefene hydrochloride injection",
  "start_marketing_date": "20231115",
  "active_numerator_strength": "2"
}

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