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United States · US · US:72241-004_2be4a232-7aa2-44f8-ba8c-f5b64677c1b7
HYDRALAZINE HYDROCHLORIDE
Orange BookUNIISPLATC C02DB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerModavar Pharmaceuticals LLC
CountryUS (United States)
ATC codeC02DB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117224100405100 TABLET in 1 BOTTLE (72241-004-05)
- ndc1172241004111000 TABLET in 1 BOTTLE (72241-004-11)
Annotations
UNII (FDA Substance ID)
FD171B778Y
HYDRALAZINE HYDROCHLORIDE
RxCUI 82027
Orange Book
A203845
AAAAAA
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": "72241-004_2be4a232-7aa2-44f8-ba8c-f5b64677c1b7",
"productndc": "72241-004",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203845",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "25MG",
"product_no": "001",
"approval_date": "Sep 18, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "50MG",
"product_no": "002",
"approval_date": "Sep 18, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "003",
"approval_date": "Sep 18, 2014"
}
],
"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": "ANDA203845",
"marketing_category": "ANDA",
"nonproprietary_name": "hydralazine hydrochloride",
"start_marketing_date": "20151229",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C02DB02.
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