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United States · US · US:55150-400_f725ae73-cab2-4a30-901c-9f8856803f3a
HYDRALAZINE HYDROCHLORIDE
Orange BookUNIISPLATC C02DB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeC02DB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11551504002525 VIAL, SINGLE-DOSE in 1 CARTON (55150-400-25) / 1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
FD171B778Y
HYDRALAZINE HYDROCHLORIDE
RxCUI 82027
Orange Book
A215147
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
"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": "55150-400_f725ae73-cab2-4a30-901c-9f8856803f3a",
"productndc": "55150-400",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "215147",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/ML",
"product_no": "001",
"approval_date": "Feb 13, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDRALAZINE HYDROCHLORIDE",
"proprietary_name": "HYDRALAZINE HYDROCHLORIDE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA215147",
"marketing_category": "ANDA",
"nonproprietary_name": "HYDRALAZINE HYDROCHLORIDE",
"start_marketing_date": "20230213",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C02DB02.
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