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United States · US · US:0641-6231_e0fe7653-bdb1-42fc-8277-fc07794f85d5
HydrALAZINE hydrochloride
Orange BookUNIISPLATC C02DB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC02DB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11064162312525 VIAL, SINGLE-DOSE in 1 CARTON (0641-6231-25) / 20 mL in 1 VIAL, SINGLE-DOSE (0641-6231-01)
Annotations
UNII (FDA Substance ID)
FD171B778Y
HYDRALAZINE HYDROCHLORIDE
RxCUI 82027
Orange Book
A213667
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
"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": "0641-6231_e0fe7653-bdb1-42fc-8277-fc07794f85d5",
"productndc": "0641-6231",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "213667",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/ML",
"product_no": "001",
"approval_date": "Dec 18, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDRALAZINE HYDROCHLORIDE",
"proprietary_name": "HydrALAZINE hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA213667",
"marketing_category": "ANDA",
"nonproprietary_name": "HydrALAZINE hydrochloride",
"start_marketing_date": "20201218",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C02DB02.
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