nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler burel pharmaceuticals, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nicardipine hydrochloride 30 mg/1

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-458
Product ID 35573-458_f47b85b1-a7d3-437b-a3db-a81e1f1716c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215377
Listing Expiration 2026-12-31
Marketing Start 2023-01-08

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 35573458
Hyphenated Format 35573-458

Supplemental Identifiers

RxCUI
858613 858616
UPC
0335573457853 0335573458850
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 ANDA215377 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (35573-458-85)
source: ndc

Packages (1)

35573-458-85 90 CAPSULE in 1 BOTTLE (35573-458-85)

Ingredients (1)

nicardipine hydrochloride (30 mg/1)

Linked Drug Pages (1)

NICARDIPINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f47b85b1-a7d3-437b-a3db-a81e1f1716c4", "openfda": {"upc": ["0335573457853", "0335573458850"], "unii": ["K5BC5011K3"], "rxcui": ["858613", "858616"], "spl_set_id": ["cb902af0-b5ad-4680-b2f2-007ef2196efe"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (35573-458-85)", "package_ndc": "35573-458-85", "marketing_start_date": "20230108"}], "brand_name": "NICARDIPINE HYDROCHLORIDE", "product_id": "35573-458_f47b85b1-a7d3-437b-a3db-a81e1f1716c4", "dosage_form": "CAPSULE", "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": "35573-458", "generic_name": "nicardipine hydrochloride", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NICARDIPINE HYDROCHLORIDE", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA215377", "marketing_category": "ANDA", "marketing_start_date": "20230108", "listing_expiration_date": "20261231"}