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United States · US · US:76420-867_259ab241-9f39-0383-e063-6394a90a040c

Naloxone Hydrochloride

Orange BookUNIISPLATC A06AH04

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeA06AH04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7642086702
    2 BLISTER PACK in 1 CARTON (76420-867-02) / 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": "76420-867_259ab241-9f39-0383-e063-6394a90a040c",
  "productndc": "76420-867",
  "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 OTC 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": "20240923",
  "active_numerator_strength": "4"
}

Related drugs

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