REDEMPLO

Orange BookUNIISPL

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

Identification

ManufacturerArrowhead Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8414102501
1 SYRINGE, GLASS in 1 CARTON (84141-025-01) / 1 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

XG9ARL6P25

PLOZASIRAN

Orange Book

N219947

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "XG9ARL6P25",
    "rxcui": null,
    "inchikey": null,
    "display_name": "PLOZASIRAN",
    "substance_type": "nucleicAcid",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "7fd37993-f85a-4af1-8bbe-133299f226ed": {
      "match": "brand_token",
      "title": "REDEMPLO (PLOZASIRAN) INJECTION, SOLUTION [ARROWHEAD PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2025-11-25"
    }
  },
  "productid": "84141-025_20832f43-4967-4ced-ac62-989dbe66c40f",
  "productndc": "84141-025",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "219947",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)",
        "product_no": "001",
        "approval_date": "Nov 18, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PLOZASIRAN",
  "proprietary_name": "REDEMPLO",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA219947",
  "marketing_category": "NDA",
  "nonproprietary_name": "plozasiran",
  "start_marketing_date": "20251119",
  "active_numerator_strength": "25"
}

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