nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler micro labs limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nicardipine hydrochloride 2.5 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-394
Product ID 42571-394_336c158b-9081-8a80-e063-6294a90a92d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216420
Listing Expiration 2026-12-31
Marketing Start 2023-11-01

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 42571394
Hyphenated Format 42571-394

Supplemental Identifiers

RxCUI
858607
UPC
0342571394882
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 ANDA216420 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (42571-394-89) / 10 mL in 1 VIAL (42571-394-88)
source: ndc

Packages (1)

42571-394-89 10 VIAL in 1 CARTON (42571-394-89) / 10 mL in 1 VIAL (42571-394-88)

Ingredients (1)

nicardipine hydrochloride (2.5 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": "336c158b-9081-8a80-e063-6294a90a92d7", "openfda": {"upc": ["0342571394882"], "unii": ["K5BC5011K3"], "rxcui": ["858607"], "spl_set_id": ["8e8611e0-7d8c-4f30-b53a-76c6588b6ef7"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (42571-394-89)  / 10 mL in 1 VIAL (42571-394-88)", "package_ndc": "42571-394-89", "marketing_start_date": "20231101"}], "brand_name": "NICARDIPINE HYDROCHLORIDE", "product_id": "42571-394_336c158b-9081-8a80-e063-6294a90a92d7", "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": "42571-394", "generic_name": "NICARDIPINE HYDROCHLORIDE", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NICARDIPINE HYDROCHLORIDE", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "ANDA216420", "marketing_category": "ANDA", "marketing_start_date": "20231101", "listing_expiration_date": "20261231"}