nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

nicardipine hydrochloride 25 mg/10mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-183
Product ID 55150-183_9a7b2c37-aca0-445f-8078-f2ea7abe0dac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211121
Listing Expiration 2026-12-31
Marketing Start 2021-04-08

Pharmacologic Class

Classes
calcium channel antagonists [moa] cytochrome p450 2c19 inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150183
Hyphenated Format 55150-183

Supplemental Identifiers

RxCUI
858607
UPC
0355150183012
UNII
K5BC5011K3

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nicardipine hydrochloride (source: ndc)
Generic Name nicardipine hydrochloride (source: ndc)
Application Number ANDA211121 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/10mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-183-10) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-183-01)
source: ndc

Packages (1)

55150-183-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-183-10) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-183-01)

Ingredients (1)

nicardipine hydrochloride (25 mg/10mL)

Linked Drug Pages (2)

NICARDIPINE HYDROCHLORIDE ndc-match (0.9) NICARDIPINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9a7b2c37-aca0-445f-8078-f2ea7abe0dac", "openfda": {"upc": ["0355150183012"], "unii": ["K5BC5011K3"], "rxcui": ["858607"], "spl_set_id": ["dcd7d173-4d8e-4282-9edf-817711340e43"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-183-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (55150-183-01)", "package_ndc": "55150-183-10", "marketing_start_date": "20210408"}], "brand_name": "NICARDIPINE HYDROCHLORIDE", "product_id": "55150-183_9a7b2c37-aca0-445f-8078-f2ea7abe0dac", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "55150-183", "generic_name": "NICARDIPINE HYDROCHLORIDE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NICARDIPINE HYDROCHLORIDE", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "25 mg/10mL"}], "application_number": "ANDA211121", "marketing_category": "ANDA", "marketing_start_date": "20210408", "listing_expiration_date": "20261231"}