nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler epic pharma, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nicardipine hydrochloride 20 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-501
Product ID 42806-501_cdaf4385-811f-4e33-9990-b4e2586b81b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074928
Listing Expiration 2026-12-31
Marketing Start 2010-05-05

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 42806501
Hyphenated Format 42806-501

Supplemental Identifiers

RxCUI
858613 858616
UPC
0342806502099 0342806501092
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 ANDA074928 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42806-501-01)
  • 500 CAPSULE in 1 BOTTLE (42806-501-05)
  • 90 CAPSULE in 1 BOTTLE (42806-501-09)
  • 1000 CAPSULE in 1 BOTTLE (42806-501-10)
source: ndc

Packages (4)

42806-501-01 100 CAPSULE in 1 BOTTLE (42806-501-01) 42806-501-05 500 CAPSULE in 1 BOTTLE (42806-501-05) 42806-501-09 90 CAPSULE in 1 BOTTLE (42806-501-09) 42806-501-10 1000 CAPSULE in 1 BOTTLE (42806-501-10)

Ingredients (1)

nicardipine hydrochloride (20 mg/1)

Linked Drug Pages (1)

Nicardipine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cdaf4385-811f-4e33-9990-b4e2586b81b3", "openfda": {"upc": ["0342806502099", "0342806501092"], "unii": ["K5BC5011K3"], "rxcui": ["858613", "858616"], "spl_set_id": ["b8f147b8-955f-4733-9178-2cfa0beb60d6"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42806-501-01)", "package_ndc": "42806-501-01", "marketing_start_date": "20100505"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (42806-501-05)", "package_ndc": "42806-501-05", "marketing_start_date": "20100505"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (42806-501-09)", "package_ndc": "42806-501-09", "marketing_start_date": "20100505"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (42806-501-10)", "package_ndc": "42806-501-10", "marketing_start_date": "20100505"}], "brand_name": "Nicardipine Hydrochloride", "product_id": "42806-501_cdaf4385-811f-4e33-9990-b4e2586b81b3", "dosage_form": "CAPSULE", "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": "42806-501", "generic_name": "Nicardipine Hydrochloride", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nicardipine Hydrochloride", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA074928", "marketing_category": "ANDA", "marketing_start_date": "20100505", "listing_expiration_date": "20261231"}