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United States · US · US:64380-734_198e8715-f4c9-4b66-9e8e-61edab911f51
HydrALAZINE Hydrochloride
Orange BookUNIISPLATC C02DB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeC02DB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116438073406100 TABLET in 1 BOTTLE (64380-734-06)
- ndc116438073407500 TABLET in 1 BOTTLE (64380-734-07)
- ndc1164380734081000 TABLET in 1 BOTTLE (64380-734-08)
Annotations
UNII (FDA Substance ID)
FD171B778Y
HYDRALAZINE HYDROCHLORIDE
RxCUI 82027
Orange Book
A200770
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": "64380-734_198e8715-f4c9-4b66-9e8e-61edab911f51",
"productndc": "64380-734",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "200770",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "25MG",
"product_no": "001",
"approval_date": "May 3, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "50MG",
"product_no": "002",
"approval_date": "May 3, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "003",
"approval_date": "May 3, 2013"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Jun 25, 2019"
}
],
"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": "ANDA200770",
"marketing_category": "ANDA",
"nonproprietary_name": "HydrALAZINE Hydrochloride",
"start_marketing_date": "20130630",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C02DB02.
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