nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler bionpharma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nicardipine hydrochloride 30 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-437
Product ID 69452-437_261ba7ea-d55b-1ba9-e063-6394a90a4c8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217555
Listing Expiration 2026-12-31
Marketing Start 2024-11-04

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 69452437
Hyphenated Format 69452-437

Supplemental Identifiers

RxCUI
858613 858616
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 ANDA217555 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (69452-437-19)
source: ndc

Packages (1)

69452-437-19 90 CAPSULE in 1 BOTTLE, PLASTIC (69452-437-19)

Ingredients (1)

nicardipine hydrochloride (30 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": "261ba7ea-d55b-1ba9-e063-6394a90a4c8c", "openfda": {"unii": ["K5BC5011K3"], "rxcui": ["858613", "858616"], "spl_set_id": ["7bed5d8c-30c2-4598-acf3-2edba825a56d"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (69452-437-19)", "package_ndc": "69452-437-19", "marketing_start_date": "20241104"}], "brand_name": "Nicardipine Hydrochloride", "product_id": "69452-437_261ba7ea-d55b-1ba9-e063-6394a90a4c8c", "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": "69452-437", "generic_name": "Nicardipine Hydrochloride", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nicardipine Hydrochloride", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA217555", "marketing_category": "ANDA", "marketing_start_date": "20241104", "listing_expiration_date": "20261231"}