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United States · US · US:71336-1003_1791a81a-d261-4b66-b699-273afe02c380

AMVUTTRA

Orange BookUNIISPLATC N07XX18

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

Identification

ManufacturerAlnylam Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN07XX18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7133610031
    1 SYRINGE, GLASS in 1 CARTON (71336-1003-1) / .5 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)
28O0WP6Z1P
VUTRISIRAN SODIUM
RxCUI 2605574
Orange Book
N215515
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "28O0WP6Z1P",
    "rxcui": "2605574",
    "inchikey": null,
    "display_name": "VUTRISIRAN SODIUM",
    "substance_type": "nucleicAcid",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "8db0facb-81b6-4006-9239-27dc6409c5d3": {
      "match": "brand_token",
      "title": "AMVUTTRA (VUTRISIRAN) INJECTION [ALNYLAM PHARMACEUTICALS, INC.]",
      "spl_version": "8",
      "published_date": "2025-11-17"
    }
  },
  "productid": "71336-1003_1791a81a-d261-4b66-b699-273afe02c380",
  "productndc": "71336-1003",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215515",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)",
        "product_no": "001",
        "approval_date": "Jun 13, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VUTRISIRAN SODIUM",
  "proprietary_name": "AMVUTTRA",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA215515",
  "marketing_category": "NDA",
  "nonproprietary_name": "VUTRISIRAN",
  "start_marketing_date": "20220613",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code N07XX18.

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