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United States · US · US:67296-1928_46e9401c-067d-0ed9-e063-6294a90aca49

Naloxone Hydrochloride

Orange BookUNIISPLATC A06AH04

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

Identification

ManufacturerRedpharm Drug
CountryUS (United States)
ATC codeA06AH04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6729619282
    2 BLISTER PACK in 1 CARTON (67296-1928-2) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A209522
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": "67296-1928_46e9401c-067d-0ed9-e063-6294a90aca49",
  "productndc": "67296-1928",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "209522",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4MG/SPRAY",
        "product_no": "001",
        "approval_date": "Apr 19, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NALOXONE HYDROCHLORIDE",
  "proprietary_name": "Naloxone Hydrochloride",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "ANDA209522",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naloxone Hydrochloride",
  "start_marketing_date": "20211222",
  "active_numerator_strength": "4"
}

Related drugs

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