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United States · US · US:82954-0100_4e308ade-33a2-4daa-acdd-af1559b90c17

RiVive

Orange BookUNIISPLATC A06AH04

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

Identification

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

Packs · 1

  • ndc11
    8295401001
    2 VIAL, SINGLE-DOSE in 1 CARTON (82954-0100-1) / .1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
N217722
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": {
    "1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d": {
      "match": "brand_token",
      "title": "RIVIVE (NALOXONE HYDROCHLORIDE) SPRAY [HARM REDUCTION THERAPEUTICS, INC.]",
      "spl_version": "2",
      "published_date": "2026-01-16"
    }
  },
  "productid": "82954-0100_4e308ade-33a2-4daa-acdd-af1559b90c17",
  "productndc": "82954-0100",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "217722",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jul 28, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NALOXONE HYDROCHLORIDE",
  "proprietary_name": "RiVive",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA217722",
  "marketing_category": "NDA",
  "nonproprietary_name": "naloxone hydrochloride",
  "start_marketing_date": "20240102",
  "active_numerator_strength": "3"
}

Related drugs

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