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United States · US · US:25208-201_d39ef44a-4e4d-459d-86bd-79394202e3ec
ZYPITAMAG
Orange BookUNIISPLATC C10AA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMedicure International Inc
CountryUS (United States)
ATC codeC10AA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11252082010990 TABLET, FILM COATED in 1 BOTTLE (25208-201-09)
- ndc112520820115500 TABLET, FILM COATED in 1 BOTTLE (25208-201-15)
Annotations
UNII (FDA Substance ID)
M5681Q5F9P
PITAVASTATIN
RxCUI 861634
Orange Book
N208379
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "M5681Q5F9P",
"rxcui": "861634",
"inchikey": "VGYFMXBACGZSIL-MCBHFWOFSA-N",
"display_name": "PITAVASTATIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c8c50e03-5cb8-43f4-bdef-8edd12f1945f": {
"match": "brand_token",
"title": "ZYPITAMAG (PITAVASTATIN MAGNESIUM) TABLET, FILM COATED [MEDICURE INTERNATIONAL INC]",
"spl_version": "14",
"published_date": "2025-12-04"
}
},
"productid": "25208-201_d39ef44a-4e4d-459d-86bd-79394202e3ec",
"productndc": "25208-201",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208379",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Jul 14, 2017"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 2MG BASE",
"product_no": "002",
"approval_date": "Jul 14, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 4MG BASE",
"product_no": "003",
"approval_date": "Jul 14, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PITAVASTATIN",
"proprietary_name": "ZYPITAMAG",
"active_ingred_unit": "mg/1",
"application_number": "NDA208379",
"marketing_category": "NDA",
"nonproprietary_name": "Pitavastatin Magnesium",
"start_marketing_date": "20180309",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code C10AA08.
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