cardene iv

Generic: nicardipine hydrochloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cardene iv
Generic Name nicardipine hydrochloride
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

nicardipine hydrochloride 2.5 mg/10mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 43066-029
Product ID 43066-029_5749599d-ff2a-42e4-aa72-cd25013feee8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019734
Listing Expiration 2027-12-31
Marketing Start 1992-01-30

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 43066029
Hyphenated Format 43066-029

Supplemental Identifiers

RxCUI
858607 858609
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 cardene iv (source: ndc)
Generic Name nicardipine hydrochloride (source: ndc)
Application Number NDA019734 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/10mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (43066-029-10) / 10 mL in 1 VIAL, SINGLE-DOSE (43066-029-01)
source: ndc

Packages (1)

43066-029-10 10 VIAL, SINGLE-DOSE in 1 CARTON (43066-029-10) / 10 mL in 1 VIAL, SINGLE-DOSE (43066-029-01)

Ingredients (1)

nicardipine hydrochloride (2.5 mg/10mL)

Linked Drug Pages (1)

CARDENE IV ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5749599d-ff2a-42e4-aa72-cd25013feee8", "openfda": {"unii": ["K5BC5011K3"], "rxcui": ["858607", "858609"], "spl_set_id": ["5749599d-ff2a-42e4-aa72-cd25013feee8"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (43066-029-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (43066-029-01)", "package_ndc": "43066-029-10", "marketing_start_date": "20251229"}], "brand_name": "CARDENE IV", "product_id": "43066-029_5749599d-ff2a-42e4-aa72-cd25013feee8", "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": "43066-029", "generic_name": "nicardipine hydrochloride", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CARDENE IV", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "2.5 mg/10mL"}], "application_number": "NDA019734", "marketing_category": "NDA", "marketing_start_date": "19920130", "listing_expiration_date": "20271231"}