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United States · US · US:68462-341_617acbb5-012a-416f-bf6c-fd766a25711c
Hydralazine Hydrochloride
Orange BookUNIISPLATC C02DB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeC02DB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116846234101100 TABLET in 1 BOTTLE (68462-341-01)
- ndc116846234105500 TABLET in 1 BOTTLE (68462-341-05)
- ndc1168462341101000 TABLET in 1 BOTTLE (68462-341-10)
Annotations
UNII (FDA Substance ID)
FD171B778Y
HYDRALAZINE HYDROCHLORIDE
RxCUI 82027
Orange Book
A090527
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": "68462-341_617acbb5-012a-416f-bf6c-fd766a25711c",
"productndc": "68462-341",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090527",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG",
"product_no": "001",
"approval_date": "May 29, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "25MG",
"product_no": "002",
"approval_date": "May 29, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "50MG",
"product_no": "003",
"approval_date": "May 29, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "004",
"approval_date": "May 29, 2009"
}
],
"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": "ANDA090527",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydralazine Hydrochloride",
"start_marketing_date": "20090529",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C02DB02.
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