ranolazine

Generic: ranolazine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ranolazine
Generic Name ranolazine
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ranolazine 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-009
Product ID 59651-009_ee3c2383-a36a-4abe-9764-89f817798f28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209081
Listing Expiration 2026-12-31
Marketing Start 2022-12-23

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 59651009
Hyphenated Format 59651-009

Supplemental Identifiers

RxCUI
616749 728231
UPC
0359651009604
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 ANDA209081 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-18)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-60)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-99)
source: ndc

Packages (3)

59651-009-18 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-18) 59651-009-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-60) 59651-009-99 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-99)

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": "ee3c2383-a36a-4abe-9764-89f817798f28", "openfda": {"nui": ["N0000175427", "N0000190114", "N0000185503", "N0000182137", "N0000187061"], "upc": ["0359651009604"], "unii": ["A6IEZ5M406"], "rxcui": ["616749", "728231"], "spl_set_id": ["49873158-5c0a-41da-86a2-369ef6b0cbc8"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-18)", "package_ndc": "59651-009-18", "marketing_start_date": "20221223"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-60)", "package_ndc": "59651-009-60", "marketing_start_date": "20221223"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-99)", "package_ndc": "59651-009-99", "marketing_start_date": "20221223"}], "brand_name": "Ranolazine", "product_id": "59651-009_ee3c2383-a36a-4abe-9764-89f817798f28", "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": "59651-009", "generic_name": "Ranolazine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ranolazine", "active_ingredients": [{"name": "RANOLAZINE", "strength": "500 mg/1"}], "application_number": "ANDA209081", "marketing_category": "ANDA", "marketing_start_date": "20221223", "listing_expiration_date": "20261231"}