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United States · US · US:68001-316_52cf32e6-c51f-6fa2-e063-6394a90adb97
Lovastatin
Orange BookUNIISPLATC C10AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBluePoint Laboratories
CountryUS (United States)
ATC codeC10AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116800131600100 TABLET in 1 BOTTLE (68001-316-00)
- ndc1168001316081000 TABLET in 1 BOTTLE (68001-316-08)
Annotations
UNII (FDA Substance ID)
9LHU78OQFD
LOVASTATIN
RxCUI 6472
Orange Book
A078296
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9LHU78OQFD",
"rxcui": "6472",
"inchikey": "PCZOHLXUXFIOCF-BXMDZJJMSA-N",
"display_name": "LOVASTATIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f5f265a6-2aa5-4205-9159-40133ae93ac0": {
"match": "brand_token",
"title": "LOVASTATIN TABLET [BRYANT RANCH PREPACK]",
"spl_version": "8",
"published_date": "2026-06-01"
}
},
"productid": "68001-316_52cf32e6-c51f-6fa2-e063-6394a90adb97",
"productndc": "68001-316",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078296",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Mar 14, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Nov 1, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "003",
"approval_date": "Nov 1, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOVASTATIN",
"proprietary_name": "Lovastatin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078296",
"marketing_category": "ANDA",
"nonproprietary_name": "lovastatin",
"start_marketing_date": "20071101",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code C10AA02.
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