🇺🇸
United States · US · US:70069-876_035cb7ef-c5d5-4752-8d43-61b8e8420330
Nicardipine Hydrochloride
Orange BookUNIISPLATC C08CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeC08CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11700698761010 POUCH in 1 CASE (70069-876-10) / 1 BAG in 1 POUCH (70069-876-01) / 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": "70069-876_035cb7ef-c5d5-4752-8d43-61b8e8420330",
"productndc": "70069-876",
"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": "20260420",
"active_numerator_strength": ".2"
}Related drugs
Other records sharing ATC code C08CA04.
- GBCardene 20mg capsulesDowelhurst Ltd
- GBCardene 20mg capsulesWaymade Healthcare Plc
- GBCardene 20mg capsulesLaboratoire X.O
- GBCardene 30mg capsulesLaboratoire X.O
- GBCardene 30mg capsulesWaymade Healthcare Plc
- GBCardene I.V. 25mg/10ml solution for infusion ampoulesImported (United States)
- 🇺🇸Cardene IVBaxter Healthcare Corporation
- 🇺🇸Cardene IVBaxter Healthcare Corporation
Access this data programmatically
Query Nicardipine Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.