Livalo

Orange BookUNIISPLATC C10AA08

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

Identification

ManufacturerKowa Pharmaceuticals America, Inc.

CountryUS (United States)

ATC codeC10AA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6686940490
90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-404-90)

Annotations

UNII (FDA Substance ID)

IYD54XEG3W

PITAVASTATIN CALCIUM

RxCUI 861640

Orange Book

N022363

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "IYD54XEG3W",
    "rxcui": "861640",
    "inchikey": "RHGYHLPFVJEAOC-FFNUKLMVSA-L",
    "display_name": "PITAVASTATIN CALCIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "44dcbf97-99ec-427c-ba50-207e0069d6d2": {
      "match": "brand_token",
      "title": "LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "11",
      "published_date": "2026-02-10"
    }
  },
  "productid": "66869-404_f558f406-3b8e-4a4b-a817-2fb2e624c79c",
  "productndc": "66869-404",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022363",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Aug 3, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Aug 3, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "003",
        "approval_date": "Aug 3, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PITAVASTATIN CALCIUM",
  "proprietary_name": "Livalo",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022363",
  "marketing_category": "NDA",
  "nonproprietary_name": "pitavastatin calcium",
  "start_marketing_date": "20190516",
  "active_numerator_strength": "4.18"
}

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