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United States · US · US:50111-397_faf6c313-03e6-4bf8-ac9f-65642ae10097
Hydralazine Hydrochloride
Orange BookUNIISPLATC C02DB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeC02DB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115011139701100 TABLET in 1 BOTTLE (50111-397-01)
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": "50111-397_faf6c313-03e6-4bf8-ac9f-65642ae10097",
"productndc": "50111-397",
"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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