RIVFLOZA

Orange BookUNIISPLATC A16AX25

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNovo Nordisk

CountryUS (United States)

ATC codeA16AX25

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0169530801
1 VIAL in 1 CARTON (0169-5308-01) / .5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

EGR9KYM536

NEDOSIRAN SODIUM

Orange Book

N215842

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "EGR9KYM536",
    "rxcui": null,
    "inchikey": null,
    "display_name": "NEDOSIRAN SODIUM",
    "substance_type": "nucleicAcid",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "ace9d4bc-4d20-4beb-9e9d-888690424833": {
      "match": "brand_token",
      "title": "RIVFLOZA (NEDOSIRAN) INJECTION, SOLUTION [NOVO NORDISK]",
      "spl_version": "4",
      "published_date": "2025-04-10"
    }
  },
  "productid": "0169-5308_758d66fb-0447-4f26-905f-595b182aebdc",
  "productndc": "0169-5308",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215842",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Sep 29, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Sep 29, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 160MG BASE/ML (EQ 160MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Sep 29, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NEDOSIRAN SODIUM",
  "proprietary_name": "RIVFLOZA",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA215842",
  "marketing_category": "NDA",
  "nonproprietary_name": "nedosiran",
  "start_marketing_date": "20240219",
  "active_numerator_strength": "80"
}

Related drugs

Other records sharing ATC code A16AX25.

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