ranolazine

Generic: ranolazine

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ranolazine
Generic Name ranolazine
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ranolazine 500 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8569
Product ID 0615-8569_2f01abe1-4355-4e2f-8d50-99fa12542add
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212284
Marketing Start 2020-04-01
Marketing End 2026-03-31

Pharmacologic Class

Established (EPC)
anti-anginal [epc]
Mechanism of Action
cytochrome p450 3a inhibitors [moa] p-glycoprotein inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] organic cation transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158569
Hyphenated Format 0615-8569

Supplemental Identifiers

RxCUI
616749
UNII
A6IEZ5M406
NUI
N0000175427 N0000190114 N0000185503 N0000182137 N0000187061

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 ranolazine (source: ndc)
Generic Name ranolazine (source: ndc)
Application Number ANDA212284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8569-39)
source: ndc

Packages (1)

0615-8569-39 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8569-39)

Ingredients (1)

ranolazine (500 mg/1)

Linked Drug Pages (1)

Ranolazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f01abe1-4355-4e2f-8d50-99fa12542add", "openfda": {"nui": ["N0000175427", "N0000190114", "N0000185503", "N0000182137", "N0000187061"], "unii": ["A6IEZ5M406"], "rxcui": ["616749"], "spl_set_id": ["96dd12c2-5409-4081-8242-4774741d9822"], "pharm_class_epc": ["Anti-anginal [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8569-39)", "package_ndc": "0615-8569-39", "marketing_end_date": "20260331", "marketing_start_date": "20250220"}], "brand_name": "Ranolazine", "product_id": "0615-8569_2f01abe1-4355-4e2f-8d50-99fa12542add", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-anginal [EPC]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0615-8569", "generic_name": "Ranolazine", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ranolazine", "active_ingredients": [{"name": "RANOLAZINE", "strength": "500 mg/1"}], "application_number": "ANDA212284", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20200401"}