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United States · US · US:82228-712_28373fa9-eaed-4941-9b38-89ebe785c2d6

Attruby

Orange BookUNIISPLATC C01EB25

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

Identification

ManufacturerBridgeBio Pharma, Inc.
CountryUS (United States)
ATC codeC01EB25
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8222871228
    4 DOSE PACK in 1 CARTON (82228-712-28) / 1 BLISTER PACK in 1 DOSE PACK / 28 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
VY9C88C2NV
ACORAMIDIS HYDROCHLORIDE
Orange Book
N216540
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "VY9C88C2NV",
    "rxcui": null,
    "inchikey": "MGFZEARHINUOMX-UHFFFAOYSA-N",
    "display_name": "ACORAMIDIS HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "913552ef-875d-4cb7-bf05-a7d20a394c38": {
      "match": "brand_token",
      "title": "ATTRUBY (ACORAMIDIS HYDROCHLORIDE) TABLET, FILM COATED [BRIDGEBIO PHARMA, INC.]",
      "spl_version": "6",
      "published_date": "2025-12-16"
    }
  },
  "productid": "82228-712_28373fa9-eaed-4941-9b38-89ebe785c2d6",
  "productndc": "82228-712",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216540",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 356MG BASE",
        "product_no": "001",
        "approval_date": "Nov 22, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACORAMIDIS HYDROCHLORIDE",
  "proprietary_name": "Attruby",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216540",
  "marketing_category": "NDA",
  "nonproprietary_name": "acoramidis hydrochloride",
  "start_marketing_date": "20241122",
  "active_numerator_strength": "356"
}

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