nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler caplin steriles limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nicardipine hydrochloride .1 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-197
Product ID 65145-197_9383f1dc-0310-4c87-a8f0-48c09a85d89b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA220243
Listing Expiration 2026-12-31
Marketing Start 2025-11-04

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 65145197
Hyphenated Format 65145-197

Supplemental Identifiers

RxCUI
858599 858603
UPC
0365145198013 0365145197016
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 ANDA220243 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 1 BAG in 1 POUCH (65145-197-01) / 200 mL in 1 BAG
source: ndc

Packages (1)

65145-197-01 1 BAG in 1 POUCH (65145-197-01) / 200 mL in 1 BAG

Ingredients (1)

nicardipine hydrochloride (.1 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": "9383f1dc-0310-4c87-a8f0-48c09a85d89b", "openfda": {"upc": ["0365145198013", "0365145197016"], "unii": ["K5BC5011K3"], "rxcui": ["858599", "858603"], "spl_set_id": ["9383f1dc-0310-4c87-a8f0-48c09a85d89b"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 POUCH (65145-197-01)  / 200 mL in 1 BAG", "package_ndc": "65145-197-01", "marketing_start_date": "20251104"}], "brand_name": "Nicardipine Hydrochloride", "product_id": "65145-197_9383f1dc-0310-4c87-a8f0-48c09a85d89b", "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": "65145-197", "generic_name": "Nicardipine Hydrochloride", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nicardipine Hydrochloride", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": ".1 mg/mL"}], "application_number": "ANDA220243", "marketing_category": "ANDA", "marketing_start_date": "20251104", "listing_expiration_date": "20261231"}