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United States · US · US:64980-686_6f4c73c0-8b68-485d-87f6-cd77746aada8
ENALAPRIL MALEATE
Orange BookUNIISPLATC C09AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeC09AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116498068601100 TABLET in 1 BOTTLE (64980-686-01)
- ndc1164980686101000 TABLET in 1 BOTTLE (64980-686-10)
Annotations
UNII (FDA Substance ID)
9O25354EPJ
ENALAPRIL MALEATE
RxCUI 203123
Orange Book
A218531
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9O25354EPJ",
"rxcui": "203123",
"inchikey": "OYFJQPXVCSSHAI-QFPUQLAESA-N",
"display_name": "ENALAPRIL MALEATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c1e4cd79-ece5-432c-bd3a-ed4633ccec70": {
"match": "brand_token",
"title": "ENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [BRYANT RANCH PREPACK]",
"spl_version": "1",
"published_date": "2026-05-29"
}
},
"productid": "64980-686_6f4c73c0-8b68-485d-87f6-cd77746aada8",
"productndc": "64980-686",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218531",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Sep 19, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "002",
"approval_date": "Sep 19, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "003",
"approval_date": "Sep 19, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "004",
"approval_date": "Sep 19, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENALAPRIL MALEATE",
"proprietary_name": "ENALAPRIL MALEATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218531",
"marketing_category": "ANDA",
"nonproprietary_name": "ENALAPRIL MALEATE",
"start_marketing_date": "20250224",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C09AA02.
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