nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nicardipine hydrochloride 25 mg/10mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-818
Product ID 65219-818_c02909f8-be8a-46ff-a3aa-9419fbd90d63
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217548
Listing Expiration 2026-12-31
Marketing Start 2024-09-11

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 65219818
Hyphenated Format 65219-818

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 ANDA217548 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/10mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (65219-818-10) / 10 mL in 1 VIAL, GLASS
  • 10 VIAL, GLASS in 1 CARTON (65219-818-13) / 10 mL in 1 VIAL, GLASS (65219-818-03)
source: ndc

Packages (2)

65219-818-10 1 VIAL, GLASS in 1 CARTON (65219-818-10) / 10 mL in 1 VIAL, GLASS 65219-818-13 10 VIAL, GLASS in 1 CARTON (65219-818-13) / 10 mL in 1 VIAL, GLASS (65219-818-03)

Ingredients (1)

nicardipine hydrochloride (25 mg/10mL)

Linked Drug Pages (1)

NICARDIPINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c02909f8-be8a-46ff-a3aa-9419fbd90d63", "openfda": {"unii": ["K5BC5011K3"], "rxcui": ["858607"], "spl_set_id": ["cdafe6cc-b03e-4e72-9d0a-6baa977149d6"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (65219-818-10)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "65219-818-10", "marketing_start_date": "20240911"}, {"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (65219-818-13)  / 10 mL in 1 VIAL, GLASS (65219-818-03)", "package_ndc": "65219-818-13", "marketing_start_date": "20251117"}], "brand_name": "NICARDIPINE HYDROCHLORIDE", "product_id": "65219-818_c02909f8-be8a-46ff-a3aa-9419fbd90d63", "dosage_form": "INJECTION", "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": "65219-818", "generic_name": "Nicardipine Hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NICARDIPINE HYDROCHLORIDE", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "25 mg/10mL"}], "application_number": "ANDA217548", "marketing_category": "ANDA", "marketing_start_date": "20240911", "listing_expiration_date": "20261231"}