VELTASSA

Orange BookUNIISPL

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

Identification

ManufacturerVifor Pharma, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5343616830
30 PACKET in 1 CARTON (53436-168-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-168-01)

Annotations

UNII (FDA Substance ID)

1FQ2RY5YHH

PATIROMER

RxCUI 1716203

Orange Book

N205739

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1FQ2RY5YHH",
    "rxcui": "1716203",
    "inchikey": null,
    "display_name": "PATIROMER",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bf002984-d6c9-46df-aecb-a07733f763c1": {
      "match": "brand_token",
      "title": "VELTASSA (PATIROMER) POWDER, FOR SUSPENSION [VIFOR PHARMA, INC.]",
      "spl_version": "23",
      "published_date": "2025-02-10"
    }
  },
  "productid": "53436-168_3e4b6452-1c7c-4f58-aee4-12fb185aaa83",
  "productndc": "53436-168",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "205739",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 8.4GM BASE/PACKET",
        "product_no": "001",
        "approval_date": "Oct 21, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 16.8GM BASE/PACKET",
        "product_no": "002",
        "approval_date": "Oct 21, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25.2GM BASE/PACKET",
        "product_no": "003",
        "approval_date": "Oct 21, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/PACKET",
        "product_no": "004",
        "approval_date": "Oct 2, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PATIROMER",
  "proprietary_name": "VELTASSA",
  "active_ingred_unit": "g/1",
  "application_number": "NDA205739",
  "marketing_category": "NDA",
  "nonproprietary_name": "patiromer",
  "start_marketing_date": "20151023",
  "active_numerator_strength": "16.8"
}

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