nicardipine hydrochloride in sodium chloride

Generic: nicardipine hydrochloride

Labeler: wg critical care, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride in sodium chloride
Generic Name nicardipine hydrochloride
Labeler wg critical care, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

nicardipine hydrochloride .2 mg/mL

Manufacturer
WG Critical Care, LLC

Identifiers & Regulatory

Product NDC 44567-851
Product ID 44567-851_9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203978
Listing Expiration 2026-12-31
Marketing Start 2025-07-10

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 44567851
Hyphenated Format 44567-851

Supplemental Identifiers

RxCUI
858599 858603
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 in sodium chloride (source: ndc)
Generic Name nicardipine hydrochloride (source: ndc)
Application Number ANDA203978 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 12 BAG in 1 CARTON (44567-851-12) / 200 mL in 1 BAG (44567-851-01)
source: ndc

Packages (1)

Ingredients (1)

nicardipine hydrochloride (.2 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d", "openfda": {"unii": ["K5BC5011K3"], "rxcui": ["858599", "858603"], "spl_set_id": ["9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d"], "manufacturer_name": ["WG Critical Care, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CARTON (44567-851-12)  / 200 mL in 1 BAG (44567-851-01)", "package_ndc": "44567-851-12", "marketing_start_date": "20250710"}], "brand_name": "Nicardipine Hydrochloride in Sodium Chloride", "product_id": "44567-851_9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d", "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": "44567-851", "generic_name": "Nicardipine Hydrochloride", "labeler_name": "WG Critical Care, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nicardipine Hydrochloride in Sodium Chloride", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": ".2 mg/mL"}], "application_number": "ANDA203978", "marketing_category": "ANDA", "marketing_start_date": "20250710", "listing_expiration_date": "20261231"}