nicardipine hydrochloride

Generic: nicardipine hydrochloride

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

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

nicardipine hydrochloride 2.5 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-204
Product ID 71288-204_cb0726e2-244f-4842-848d-7591dfbc96bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216819
Listing Expiration 2026-12-31
Marketing Start 2025-08-20

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 71288204
Hyphenated Format 71288-204

Supplemental Identifiers

RxCUI
858607
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 ANDA216819 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-204-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-204-10)
source: ndc

Packages (1)

71288-204-11 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-204-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-204-10)

Ingredients (1)

nicardipine hydrochloride (2.5 mg/mL)

Linked Drug Pages (1)

nicardipine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "cb0726e2-244f-4842-848d-7591dfbc96bb", "openfda": {"unii": ["K5BC5011K3"], "rxcui": ["858607"], "spl_set_id": ["372a4381-7302-4df7-81bb-a9521907f867"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-204-11)  / 10 mL in 1 VIAL, SINGLE-DOSE (71288-204-10)", "package_ndc": "71288-204-11", "marketing_start_date": "20250820"}], "brand_name": "nicardipine hydrochloride", "product_id": "71288-204_cb0726e2-244f-4842-848d-7591dfbc96bb", "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": "71288-204", "generic_name": "nicardipine hydrochloride", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nicardipine hydrochloride", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "ANDA216819", "marketing_category": "ANDA", "marketing_start_date": "20250820", "listing_expiration_date": "20261231"}