nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nicardipine hydrochloride .1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9634
Product ID 0143-9634_299a0b28-ebf0-4753-983d-b9a16158d83c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022276
Listing Expiration 2026-12-31
Marketing Start 2016-04-07

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 01439634
Hyphenated Format 0143-9634

Supplemental Identifiers

RxCUI
858599 858603 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 NDA022276 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 CARTON (0143-9634-10) / 200 mL in 1 BAG (0143-9634-01)
source: ndc

Packages (1)

0143-9634-10 10 BAG in 1 CARTON (0143-9634-10) / 200 mL in 1 BAG (0143-9634-01)

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": "299a0b28-ebf0-4753-983d-b9a16158d83c", "openfda": {"unii": ["K5BC5011K3"], "rxcui": ["858599", "858603", "858607"], "spl_set_id": ["18fb1c2b-0c1e-436c-a5b6-d4840b5da228"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CARTON (0143-9634-10)  / 200 mL in 1 BAG (0143-9634-01)", "package_ndc": "0143-9634-10", "marketing_start_date": "20160407"}], "brand_name": "Nicardipine Hydrochloride", "product_id": "0143-9634_299a0b28-ebf0-4753-983d-b9a16158d83c", "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": "0143-9634", "generic_name": "Nicardipine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nicardipine Hydrochloride", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": ".1 mg/mL"}], "application_number": "NDA022276", "marketing_category": "NDA", "marketing_start_date": "20160407", "listing_expiration_date": "20261231"}