ranolazine

Generic: ranolazine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ranolazine
Generic Name ranolazine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ranolazine 500 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-518
Product ID 71610-518_1524482d-40bd-a0f9-e063-6394a90a1a37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212781
Listing Expiration 2026-12-31
Marketing Start 2020-10-27

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 71610518
Hyphenated Format 71610-518

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 ANDA212781 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1800 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-42)
  • 3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-83)
source: ndc

Packages (2)

71610-518-42 1800 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-42) 71610-518-83 3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-83)

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": "1524482d-40bd-a0f9-e063-6394a90a1a37", "openfda": {"nui": ["N0000175427", "N0000190114", "N0000185503", "N0000182137", "N0000187061"], "unii": ["A6IEZ5M406"], "rxcui": ["616749"], "spl_set_id": ["abb32182-46ba-49d2-b2ac-13de2ecf802d"], "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": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1800 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-42)", "package_ndc": "71610-518-42", "marketing_start_date": "20240401"}, {"sample": false, "description": "3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-83)", "package_ndc": "71610-518-83", "marketing_start_date": "20210122"}], "brand_name": "Ranolazine", "product_id": "71610-518_1524482d-40bd-a0f9-e063-6394a90a1a37", "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": "71610-518", "generic_name": "RANOLAZINE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ranolazine", "active_ingredients": [{"name": "RANOLAZINE", "strength": "500 mg/1"}], "application_number": "ANDA212781", "marketing_category": "ANDA", "marketing_start_date": "20201027", "listing_expiration_date": "20261231"}