pitavastatin calcium

Orange BookUNIISPLATC C10AA08

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeC10AA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6838248216
90 TABLET in 1 BOTTLE (68382-482-16)

Annotations

UNII (FDA Substance ID)

IYD54XEG3W

PITAVASTATIN CALCIUM

RxCUI 861640

Orange Book

A206047

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": "68382-482_f34ff300-0613-4b94-9fcf-475d6494ea7e",
  "productndc": "68382-482",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206047",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Feb 22, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Feb 22, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "003",
        "approval_date": "Feb 22, 2023"
      }
    ],
    "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": "ANDA206047",
  "marketing_category": "ANDA",
  "nonproprietary_name": "pitavastatin calcium",
  "start_marketing_date": "20231102",
  "active_numerator_strength": "2"
}

Related drugs

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