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United States · US · US:65145-197_9383f1dc-0310-4c87-a8f0-48c09a85d89b
Nicardipine Hydrochloride
Orange BookUNIISPLATC C08CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeC08CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165145197011 BAG in 1 POUCH (65145-197-01) / 200 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
K5BC5011K3
NICARDIPINE HYDROCHLORIDE
RxCUI 235230
Orange Book
A220243
APAP
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": "65145-197_9383f1dc-0310-4c87-a8f0-48c09a85d89b",
"productndc": "65145-197",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "220243",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/200ML (0.1MG/ML)",
"product_no": "001",
"approval_date": "Oct 22, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "40MG/200ML (0.2MG/ML)",
"product_no": "002",
"approval_date": "Oct 22, 2025"
}
],
"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": "ANDA220243",
"marketing_category": "ANDA",
"nonproprietary_name": "Nicardipine Hydrochloride",
"start_marketing_date": "20251104",
"active_numerator_strength": ".1"
}Related drugs
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