Pitavastatin

Orange BookUNIISPLATC C10AA08

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeC10AA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0832605090
90 TABLET in 1 BOTTLE (0832-6050-90)

Annotations

UNII (FDA Substance ID)

IYD54XEG3W

PITAVASTATIN CALCIUM

RxCUI 861640

Orange Book

A205955

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": "0832-6050_266944ba-7e94-48c6-e063-6394a90adc2e",
  "productndc": "0832-6050",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205955",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Feb 3, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Feb 3, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "003",
        "approval_date": "Feb 3, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PITAVASTATIN CALCIUM",
  "proprietary_name": "Pitavastatin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205955",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pitavastatin Calcium",
  "start_marketing_date": "20231102",
  "active_numerator_strength": "4"
}

Related drugs

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