Back to search
🇺🇸

United States · US · US:51662-1620_100bc933-5bf3-8de2-e063-6294a90a7ba6

NALOXONE HCl

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
    5166216201
    .1 mL in 1 VIAL, SINGLE-DOSE (51662-1620-1)
  • ndc11
    5166216202
    2 VIAL, SINGLE-DOSE in 1 CARTON (51662-1620-2) / .1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A211951
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": "NASAL",
  "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": "51662-1620_100bc933-5bf3-8de2-e063-6294a90a7ba6",
  "productndc": "51662-1620",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "211951",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jun 21, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NALOXONE HYDROCHLORIDE",
  "proprietary_name": "NALOXONE HCl",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "ANDA211951",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NALOXONE HCl",
  "start_marketing_date": "20230410",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code A06AH04.

Access this data programmatically

Query NALOXONE HCl and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.