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United States · US · US:70710-2010_bf108728-380c-41b5-a730-1ddd2c0051ae
Nicardipine Hydrochloride
Orange BookUNIISPLATC C08CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC08CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11707102010990 CAPSULE in 1 BOTTLE (70710-2010-9)
Annotations
UNII (FDA Substance ID)
K5BC5011K3
NICARDIPINE HYDROCHLORIDE
RxCUI 235230
Orange Book
A218638
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "K5BC5011K3",
"rxcui": "235230",
"inchikey": "AIKVCUNQWYTVTO-UHFFFAOYSA-N",
"display_name": "NICARDIPINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b0e2bed3-f928-43ab-a05c-275bedc9856f": {
"match": "brand_token",
"title": "NICARDIPINE HYDROCHLORIDE INJECTION [LIFESTAR PHARMA LLC]",
"spl_version": "3",
"published_date": "2026-04-27"
}
},
"productid": "70710-2010_bf108728-380c-41b5-a730-1ddd2c0051ae",
"productndc": "70710-2010",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "218638",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "20MG",
"product_no": "001",
"approval_date": "Jun 25, 2025"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG",
"product_no": "002",
"approval_date": "Jun 25, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NICARDIPINE HYDROCHLORIDE",
"proprietary_name": "Nicardipine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218638",
"marketing_category": "ANDA",
"nonproprietary_name": "Nicardipine Hydrochloride",
"start_marketing_date": "20250801",
"active_numerator_strength": "20"
}Related drugs
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