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United States · US · US:51662-1242_0ff862db-44cb-aac2-e063-6394a90a8a5d

NALOXONE HCI

Orange BookUNIISPLATC A06AH04

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

Identification

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

Packs · 2

  • ndc11
    5166212421
    1 mL in 1 VIAL (51662-1242-1)
  • ndc11
    5166212423
    50 POUCH in 1 CASE (51662-1242-3) / 1 mL in 1 POUCH (51662-1242-2)

Annotations

UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A070256
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": "51662-1242_0ff862db-44cb-aac2-e063-6394a90a8a5d",
  "productndc": "51662-1242",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "070256",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "0.4MG/ML",
        "product_no": "001",
        "approval_date": "Jan 7, 1987"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NALOXONE HYDROCHLORIDE",
  "proprietary_name": "NALOXONE HCI",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA070256",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NALOXONE HCI",
  "start_marketing_date": "20180818",
  "active_numerator_strength": ".4"
}

Related drugs

Other records sharing ATC code A06AH04.

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