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United States · US · US:50742-246_3ba1968f-1fbf-4136-8bcd-c2af2fc93a83
Isosorbide dinitrate and hydralazine hydrochloride
Orange BookUNIISPLATC C02DB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeC02DB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115074224618180 TABLET in 1 BOTTLE (50742-246-18)
- ndc11507422469090 TABLET in 1 BOTTLE (50742-246-90)
Annotations
UNII (FDA Substance ID)
FD171B778Y
HYDRALAZINE HYDROCHLORIDE
RxCUI 82027
Orange Book
A215586
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "FD171B778Y",
"rxcui": "82027",
"inchikey": "ZUXNZUWOTSUBMN-UHFFFAOYSA-N",
"display_name": "HYDRALAZINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c": {
"match": "brand_token",
"title": "ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]",
"spl_version": "13",
"published_date": "2026-05-13"
}
},
"productid": "50742-246_3ba1968f-1fbf-4136-8bcd-c2af2fc93a83",
"productndc": "50742-246",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "215586",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "37.5MG;20MG",
"product_no": "001",
"approval_date": "Apr 6, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE",
"proprietary_name": "Isosorbide dinitrate and hydralazine hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA215586",
"marketing_category": "ANDA",
"nonproprietary_name": "Isosorbide dinitrate and hydralazine hydrochloride",
"start_marketing_date": "20220412",
"active_numerator_strength": "37.5; 20"
}Related drugs
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