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United States · US · US:82432-103_434901d7-2140-d6d8-e063-6394a90a07c4
NICARDIPINE HYDROCHLORIDE
Orange BookUNIISPLATC C08CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChengdu Shuode Pharmaceutical Co., Ltd
CountryUS (United States)
ATC codeC08CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1182432103011 VIAL, GLASS in 1 CARTON (82432-103-01) / 10 mL in 1 VIAL, GLASS
- ndc11824321030210 VIAL, GLASS in 1 CARTON (82432-103-02) / 10 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
K5BC5011K3
NICARDIPINE HYDROCHLORIDE
RxCUI 235230
Orange Book
A217548
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": "82432-103_434901d7-2140-d6d8-e063-6394a90a07c4",
"productndc": "82432-103",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "217548",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "25MG/10ML (2.5MG/ML)",
"product_no": "001",
"approval_date": "Sep 6, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NICARDIPINE HYDROCHLORIDE",
"proprietary_name": "NICARDIPINE HYDROCHLORIDE",
"active_ingred_unit": "mg/10mL",
"application_number": "ANDA217548",
"marketing_category": "ANDA",
"nonproprietary_name": "Nicardipine Hydrochloride",
"start_marketing_date": "20240911",
"active_numerator_strength": "25"
}Related drugs
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