ranolazine

Generic: ranolazine

Labeler: i3 pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ranolazine
Generic Name ranolazine
Labeler i3 pharmaceuticals, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ranolazine 500 mg/1

Manufacturer
i3 Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 72319-021
Product ID 72319-021_163908d8-6b41-4e68-b14c-76faa57c7ac0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213517
Listing Expiration 2026-12-31
Marketing Start 2022-06-15

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 72319021
Hyphenated Format 72319-021

Supplemental Identifiers

RxCUI
616749 728231
UNII
A6IEZ5M406
NUI
N0000175427 N0000190114 N0000185503 N0000182137 N0000187061

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 ranolazine (source: ndc)
Generic Name ranolazine (source: ndc)
Application Number ANDA213517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-021-02)
source: ndc

Packages (1)

72319-021-02 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-021-02)

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": "163908d8-6b41-4e68-b14c-76faa57c7ac0", "openfda": {"nui": ["N0000175427", "N0000190114", "N0000185503", "N0000182137", "N0000187061"], "unii": ["A6IEZ5M406"], "rxcui": ["616749", "728231"], "spl_set_id": ["de3185bf-448a-15f7-e053-2995a90a9a2e"], "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": ["i3 Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-021-02)", "package_ndc": "72319-021-02", "marketing_start_date": "20220615"}], "brand_name": "RANOLAZINE", "product_id": "72319-021_163908d8-6b41-4e68-b14c-76faa57c7ac0", "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": "72319-021", "generic_name": "RANOLAZINE", "labeler_name": "i3 Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RANOLAZINE", "active_ingredients": [{"name": "RANOLAZINE", "strength": "500 mg/1"}], "application_number": "ANDA213517", "marketing_category": "ANDA", "marketing_start_date": "20220615", "listing_expiration_date": "20261231"}