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United States · US · US:33342-376_f9f56326-6d72-47d3-89ac-3625b8a6d713
Hydralazine Hydrochloride
Orange BookUNIISPLATC C02DB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeC02DB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc113334237611100 TABLET in 1 BOTTLE (33342-376-11)
- ndc11333423761210 BLISTER PACK in 1 CARTON (33342-376-12) / 10 TABLET in 1 BLISTER PACK
- ndc1133342376441000 TABLET in 1 BOTTLE (33342-376-44)
Annotations
UNII (FDA Substance ID)
FD171B778Y
HYDRALAZINE HYDROCHLORIDE
RxCUI 82027
Orange Book
A211010
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": "33342-376_f9f56326-6d72-47d3-89ac-3625b8a6d713",
"productndc": "33342-376",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211010",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 21, 2024"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG",
"product_no": "002",
"approval_date": "Aug 21, 2024"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "50MG",
"product_no": "003",
"approval_date": "Aug 21, 2024"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "100MG",
"product_no": "004",
"approval_date": "Aug 21, 2024"
}
],
"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": "ANDA211010",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydralazine Hydrochloride",
"start_marketing_date": "20240826",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C02DB02.
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