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United States · US · US:71336-1002_6ef869cb-8ccd-4339-9991-0fab45da1fbd

OXLUMO

Orange BookUNIISPLATC A16AX18

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

Identification

ManufacturerAlnylam Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA16AX18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7133610021
    1 VIAL, SINGLE-USE in 1 CARTON (71336-1002-1) / .5 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
67P6XH37HD
LUMASIRAN SODIUM
RxCUI 2467161
Orange Book
N214103
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "67P6XH37HD",
    "rxcui": "2467161",
    "inchikey": null,
    "display_name": "LUMASIRAN SODIUM",
    "substance_type": "nucleicAcid",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "16985a31-f5e4-4557-9266-fc78d4bc5055": {
      "match": "brand_token",
      "title": "OXLUMO (LUMASIRAN) INJECTION, SOLUTION [ALNYLAM PHARMACEUTICALS, INC.]",
      "spl_version": "9",
      "published_date": "2025-12-15"
    }
  },
  "productid": "71336-1002_6ef869cb-8ccd-4339-9991-0fab45da1fbd",
  "productndc": "71336-1002",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214103",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)",
        "product_no": "001",
        "approval_date": "Nov 23, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LUMASIRAN SODIUM",
  "proprietary_name": "OXLUMO",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA214103",
  "marketing_category": "NDA",
  "nonproprietary_name": "lumasiran",
  "start_marketing_date": "20201123",
  "active_numerator_strength": "94.5"
}

Related drugs

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