🇺🇸
United States · US · US:65862-309_34bf0456-37d0-4d7d-a585-1555b7bc9373
Fosinopril Sodium and Hydrochlorothiazide
Orange BookUNIISPLATC C09AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC09AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116586230901100 TABLET in 1 BOTTLE (65862-309-01)
- ndc11658623093030 TABLET in 1 BOTTLE (65862-309-30)
- ndc1165862309991000 TABLET in 1 BOTTLE (65862-309-99)
Annotations
UNII (FDA Substance ID)
NW2RTH6T2N
FOSINOPRIL SODIUM
RxCUI 227278
Orange Book
A079245
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "NW2RTH6T2N",
"rxcui": "227278",
"inchikey": "TVTJZMHAIQQZTL-WATAJHSMSA-M",
"display_name": "FOSINOPRIL SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ff1323cc-7ad8-488d-94a7-a11555db78a7": {
"match": "brand_token",
"title": "FOSINOPRIL SODIUM TABLET [CHARTWELL RX, LLC]",
"spl_version": "4",
"published_date": "2025-11-17"
}
},
"productid": "65862-309_34bf0456-37d0-4d7d-a585-1555b7bc9373",
"productndc": "65862-309",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "079245",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;12.5MG",
"product_no": "001",
"approval_date": "Jul 9, 2009"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "20MG;12.5MG",
"product_no": "002",
"approval_date": "Jul 9, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE",
"proprietary_name": "Fosinopril Sodium and Hydrochlorothiazide",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA079245",
"marketing_category": "ANDA",
"nonproprietary_name": "Fosinopril Sodium and Hydrochlorothiazide",
"start_marketing_date": "20090709",
"active_numerator_strength": "20; 12.5"
}Related drugs
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