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United States · US · US:73556-168_55ca1a31-6002-420e-b804-8a5137df45d4

TAVNEOS

Orange BookUNIISPLATC L04AJ05

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

Identification

ManufacturerChemoCentryx, Inc.
CountryUS (United States)
ATC codeL04AJ05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7355616801
    1 BOTTLE, PLASTIC in 1 CARTON (73556-168-01) / 180 CAPSULE in 1 BOTTLE, PLASTIC
  • ndc11
    7355616802
    1 BOTTLE, PLASTIC in 1 CARTON (73556-168-02) / 30 CAPSULE in 1 BOTTLE, PLASTIC
  • ndc11
    7355616896
    1 BOTTLE, PLASTIC in 1 CARTON (73556-168-96) / 30 CAPSULE in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
O880NM097T
AVACOPAN
RxCUI 2572100
Orange Book
N214487
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "O880NM097T",
    "rxcui": "2572100",
    "inchikey": "PUKBOVABABRILL-YZNIXAGQSA-N",
    "display_name": "AVACOPAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c93cbc0b-29a3-46a5-9c85-41815ea5cf4a": {
      "match": "brand_token",
      "title": "TAVNEOS (AVACOPAN) CAPSULE [CHEMOCENTRYX, INC.]",
      "spl_version": "13",
      "published_date": "2025-06-30"
    }
  },
  "productid": "73556-168_55ca1a31-6002-420e-b804-8a5137df45d4",
  "productndc": "73556-168",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "214487",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 7, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AVACOPAN",
  "proprietary_name": "TAVNEOS",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214487",
  "marketing_category": "NDA",
  "nonproprietary_name": "avacopan",
  "start_marketing_date": "20211018",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code L04AJ05.

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