nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

nicardipine hydrochloride 2.5 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-0735
Product ID 0517-0735_92ab3adc-2097-490a-a0b3-fa3fac098a2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090534
Listing Expiration 2026-12-31
Marketing Start 2020-05-08

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 05170735
Hyphenated Format 0517-0735

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 ANDA090534 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0517-0735-10) / 10 mL in 1 VIAL (0517-0735-01)
source: ndc

Packages (1)

0517-0735-10 10 VIAL in 1 CARTON (0517-0735-10) / 10 mL in 1 VIAL (0517-0735-01)

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": "92ab3adc-2097-490a-a0b3-fa3fac098a2a", "openfda": {"unii": ["K5BC5011K3"], "rxcui": ["858607"], "spl_set_id": ["76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0517-0735-10)  / 10 mL in 1 VIAL (0517-0735-01)", "package_ndc": "0517-0735-10", "marketing_start_date": "20200508"}], "brand_name": "Nicardipine Hydrochloride", "product_id": "0517-0735_92ab3adc-2097-490a-a0b3-fa3fac098a2a", "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": "0517-0735", "generic_name": "nicardipine hydrochloride", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nicardipine Hydrochloride", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "ANDA090534", "marketing_category": "ANDA", "marketing_start_date": "20200508", "listing_expiration_date": "20261231"}