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United States · US · US:43353-124_66435209-390b-4344-9b5b-47c9c2d92e2f
Hydralazine Hydrochloride
Orange BookUNIISPLATC C02DB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeC02DB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143353124054200 TABLET in 1 BOTTLE (43353-124-05)
Annotations
UNII (FDA Substance ID)
FD171B778Y
HYDRALAZINE HYDROCHLORIDE
RxCUI 82027
Orange Book
A089098
AA
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": {
"a1066707-2391-4918-8ded-600c017fde48": {
"match": "brand_token",
"title": "HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC]",
"spl_version": "4",
"published_date": "2026-06-01"
}
},
"productid": "43353-124_66435209-390b-4344-9b5b-47c9c2d92e2f",
"productndc": "43353-124",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "089098",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "001",
"approval_date": "Dec 18, 1985"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDRALAZINE HYDROCHLORIDE",
"proprietary_name": "Hydralazine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA089098",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydralazine Hydrochloride",
"start_marketing_date": "19900930",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code C02DB02.
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