nicardipine hydrochloride

Generic: nicardipine

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine
Labeler amneal pharmaceuticals ny llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nicardipine hydrochloride 30 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2692
Product ID 69238-2692_8f57d96f-7e5b-409f-9e21-c3ed67369716
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218202
Listing Expiration 2026-12-31
Marketing Start 2024-10-03

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 692382692
Hyphenated Format 69238-2692

Supplemental Identifiers

RxCUI
858613 858616
UPC
0369238269215 0369238269116
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 (source: ndc)
Application Number ANDA218202 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (69238-2692-1)
source: ndc

Packages (1)

69238-2692-1 90 CAPSULE in 1 BOTTLE (69238-2692-1)

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": "8f57d96f-7e5b-409f-9e21-c3ed67369716", "openfda": {"upc": ["0369238269215", "0369238269116"], "unii": ["K5BC5011K3"], "rxcui": ["858613", "858616"], "spl_set_id": ["79304b0f-53d3-4065-8c81-7031d1141694"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (69238-2692-1)", "package_ndc": "69238-2692-1", "marketing_start_date": "20241003"}], "brand_name": "Nicardipine hydrochloride", "product_id": "69238-2692_8f57d96f-7e5b-409f-9e21-c3ed67369716", "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": "69238-2692", "generic_name": "Nicardipine", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nicardipine hydrochloride", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA218202", "marketing_category": "ANDA", "marketing_start_date": "20241003", "listing_expiration_date": "20261231"}