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United States · US · US:51662-1544_10352ea7-15c5-5c6c-e063-6394a90ae130

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 · 2

  • ndc11
    5166215441
    1 mL in 1 VIAL, SINGLE-DOSE (51662-1544-1)
  • ndc11
    5166215443
    10 POUCH in 1 CASE (51662-1544-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1544-2) / 1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A212455
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": "51662-1544_10352ea7-15c5-5c6c-e063-6394a90ae130",
  "productndc": "51662-1544",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212455",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.4MG/ML",
        "product_no": "001",
        "approval_date": "Oct 15, 2019"
      }
    ],
    "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": "ANDA212455",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NALOXONE HYDROCHLORIDE",
  "start_marketing_date": "20210808",
  "active_numerator_strength": ".4"
}

Related drugs

Other records sharing ATC code A06AH04.

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