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United States · US · US:65162-031_ab7d1d71-229c-4528-9c2d-59d268c48c25
Pitavastatin
Orange BookUNIISPLATC C10AA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeC10AA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11651620310330 TABLET, FILM COATED in 1 BOTTLE (65162-031-03)
- ndc11651620310990 TABLET, FILM COATED in 1 BOTTLE (65162-031-09)
- ndc116516203150500 TABLET, FILM COATED in 1 BOTTLE (65162-031-50)
Annotations
UNII (FDA Substance ID)
IYD54XEG3W
PITAVASTATIN CALCIUM
RxCUI 861640
Orange Book
A205961
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": "65162-031_ab7d1d71-229c-4528-9c2d-59d268c48c25",
"productndc": "65162-031",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "205961",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Aug 20, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "002",
"approval_date": "Aug 20, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "003",
"approval_date": "Aug 20, 2024"
}
],
"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": "ANDA205961",
"marketing_category": "ANDA",
"nonproprietary_name": "Pitavastatin",
"start_marketing_date": "20240821",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code C10AA08.
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