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United States · US · US:0517-0735_92ab3adc-2097-490a-a0b3-fa3fac098a2a
Nicardipine Hydrochloride
Orange BookUNIISPLATC C08CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Regent, Inc.
CountryUS (United States)
ATC codeC08CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11051707351010 VIAL in 1 CARTON (0517-0735-10) / 10 mL in 1 VIAL (0517-0735-01)
Annotations
UNII (FDA Substance ID)
K5BC5011K3
NICARDIPINE HYDROCHLORIDE
RxCUI 235230
Orange Book
A090534
AP
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": "INTRAVENOUS",
"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": "0517-0735_92ab3adc-2097-490a-a0b3-fa3fac098a2a",
"productndc": "0517-0735",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "090534",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "25MG/10ML (2.5MG/ML)",
"product_no": "001",
"approval_date": "Nov 17, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NICARDIPINE HYDROCHLORIDE",
"proprietary_name": "Nicardipine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA090534",
"marketing_category": "ANDA",
"nonproprietary_name": "nicardipine hydrochloride",
"start_marketing_date": "20200508",
"active_numerator_strength": "2.5"
}Related drugs
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