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United States · US · US:51662-1426_2b38388a-7ffd-a3f9-e063-6394a90a3566

NALOXONE HYDROCHLORIDE

Orange BookUNIISPLATC A06AH04

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeA06AH04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5166214261
    1 VIAL, GLASS in 1 CARTON (51662-1426-1) / 10 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A207634
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "F850569PQR",
    "rxcui": "203192",
    "inchikey": "RGPDIGOSVORSAK-STHHAXOLSA-N",
    "display_name": "NALOXONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "8535cc84-ad4a-4d67-8480-fb5a2e3406f8": {
      "match": "brand_token",
      "title": "NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "35",
      "published_date": "2026-05-28"
    }
  },
  "productid": "51662-1426_2b38388a-7ffd-a3f9-e063-6394a90a3566",
  "productndc": "51662-1426",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "207634",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.4MG/ML",
        "product_no": "001",
        "approval_date": "Jul 26, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NALOXONE HYDROCHLORIDE",
  "proprietary_name": "NALOXONE HYDROCHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA207634",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NALOXONE HYDROCHLORIDE",
  "start_marketing_date": "20200110",
  "active_numerator_strength": ".4"
}

Related drugs

Other records sharing ATC code A06AH04.

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