pitavastatin calcium

Orange BookUNIISPLATC C10AA08

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

Identification

ManufacturerXLCare Pharmaceuticals Inc.

CountryUS (United States)

ATC codeC10AA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7286529190
90 TABLET, FILM COATED in 1 BOTTLE (72865-291-90)

Annotations

UNII (FDA Substance ID)

IYD54XEG3W

PITAVASTATIN CALCIUM

RxCUI 861640

Orange Book

A205977

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": {
    "0f11ee80-871e-4f13-e063-6394a90af19d": {
      "match": "brand_token",
      "title": "PITAVASTATIN (PITAVASTATIN CALCIUM) TABLET, FILM COATED [AVKARE]",
      "spl_version": "2",
      "published_date": "2026-01-19"
    }
  },
  "productid": "72865-291_3fef3397-a028-b301-e063-6394a90a913f",
  "productndc": "72865-291",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205977",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Apr 30, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Apr 30, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "003",
        "approval_date": "Apr 30, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PITAVASTATIN CALCIUM",
  "proprietary_name": "pitavastatin calcium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205977",
  "marketing_category": "ANDA",
  "nonproprietary_name": "pitavastatin calcium",
  "start_marketing_date": "20250918",
  "active_numerator_strength": "1"
}

Related drugs

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