🇺🇸
United States · US · US:71610-562_547e8073-67bc-4f54-bcc9-0fb525db6687
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 · 4
- ndc11716105626090 TABLET in 1 BOTTLE (71610-562-60)
- ndc117161056280180 TABLET in 1 BOTTLE (71610-562-80)
- ndc117161056292270 TABLET in 1 BOTTLE (71610-562-92)
- ndc117161056298540 TABLET in 1 BOTTLE (71610-562-98)
Annotations
UNII (FDA Substance ID)
FD171B778Y
HYDRALAZINE HYDROCHLORIDE
RxCUI 82027
Orange Book
A205236
AAAAAAAA
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": "71610-562_547e8073-67bc-4f54-bcc9-0fb525db6687",
"productndc": "71610-562",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "205236",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG",
"product_no": "001",
"approval_date": "May 26, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "25MG",
"product_no": "002",
"approval_date": "May 26, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "50MG",
"product_no": "003",
"approval_date": "May 26, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "004",
"approval_date": "May 26, 2017"
}
],
"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": "ANDA205236",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydralazine Hydrochloride",
"start_marketing_date": "20210304",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C02DB02.
Access this data programmatically
Query Hydralazine Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.