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United States · US · US:69097-008_d477e259-4e07-433c-b230-d3dd63331866
NICARDIPINE HYDROCHLORIDE
Orange BookUNIISPLATC C08CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeC08CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11690970082210 BAG in 1 CARTON (69097-008-22) / 200 mL in 1 BAG (69097-008-45)
Annotations
UNII (FDA Substance ID)
CZ5312222S
NICARDIPINE
RxCUI 7396
Orange Book
A215592
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "CZ5312222S",
"rxcui": "7396",
"inchikey": "ZBBHBTPTTSWHBA-UHFFFAOYSA-N",
"display_name": "NICARDIPINE",
"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": "69097-008_d477e259-4e07-433c-b230-d3dd63331866",
"productndc": "69097-008",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "215592",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/200ML (0.1MG/ML)",
"product_no": "001",
"approval_date": "Sep 24, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "40MG/200ML (0.2MG/ML)",
"product_no": "002",
"approval_date": "Sep 24, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NICARDIPINE",
"proprietary_name": "NICARDIPINE HYDROCHLORIDE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA215592",
"marketing_category": "ANDA",
"nonproprietary_name": "nicardipine hydrochloride",
"start_marketing_date": "20241002",
"active_numerator_strength": ".2"
}Related drugs
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