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United States · US · US:70771-1118_8eab99e7-f5e0-4b8a-8cc6-2d90618ebf93
ZYPITAMAG
Orange BookUNIISPLATC C10AA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeC10AA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc1170771111801000 TABLET, FILM COATED in 1 BOTTLE (70771-1118-0)
- ndc117077111181100 TABLET, FILM COATED in 1 BOTTLE (70771-1118-1)
- ndc11707711118330 TABLET, FILM COATED in 1 BOTTLE (70771-1118-3)
- ndc11707711118410 BLISTER PACK in 1 CARTON (70771-1118-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc117077111185500 TABLET, FILM COATED in 1 BOTTLE (70771-1118-5)
- ndc1170771111871 BLISTER PACK in 1 CARTON (70771-1118-7) / 7 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11707711118990 TABLET, FILM COATED in 1 BOTTLE (70771-1118-9)
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": "70771-1118_8eab99e7-f5e0-4b8a-8cc6-2d90618ebf93",
"productndc": "70771-1118",
"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": "4"
}Related drugs
Other records sharing ATC code C10AA08.
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