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United States · US · US:42291-907_48843604-c6e9-1aec-e063-6294a90aea80
Pitavastatin
Orange BookUNIISPLATC C10AA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvKARE
CountryUS (United States)
ATC codeC10AA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11422919079090 TABLET, FILM COATED in 1 BOTTLE (42291-907-90)
Annotations
UNII (FDA Substance ID)
IYD54XEG3W
PITAVASTATIN CALCIUM
RxCUI 861640
Orange Book
A205932
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": "42291-907_48843604-c6e9-1aec-e063-6294a90aea80",
"productndc": "42291-907",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "205932",
"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": "ANDA205932",
"marketing_category": "ANDA",
"nonproprietary_name": "pitavastatin calcium",
"start_marketing_date": "20240116",
"active_numerator_strength": "4.18"
}Related drugs
Other records sharing ATC code C10AA08.
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