ranolazine

Generic: ranolazine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ranolazine
Generic Name ranolazine
Labeler american health packaging
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ranolazine 500 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-549
Product ID 60687-549_23955366-9210-f95f-e063-6394a90a7e99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210054
Listing Expiration 2026-12-31
Marketing Start 2020-08-19

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 60687549
Hyphenated Format 60687-549

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 ANDA210054 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-549-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-549-11)
source: ndc

Packages (1)

60687-549-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-549-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-549-11)

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": "23955366-9210-f95f-e063-6394a90a7e99", "openfda": {"nui": ["N0000175427", "N0000190114", "N0000185503", "N0000182137", "N0000187061"], "unii": ["A6IEZ5M406"], "rxcui": ["616749"], "spl_set_id": ["90c5a0c2-542c-467e-9c0c-ef320534c560"], "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": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-549-21)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-549-11)", "package_ndc": "60687-549-21", "marketing_start_date": "20200819"}], "brand_name": "Ranolazine", "product_id": "60687-549_23955366-9210-f95f-e063-6394a90a7e99", "dosage_form": "TABLET, 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": "60687-549", "generic_name": "Ranolazine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ranolazine", "active_ingredients": [{"name": "RANOLAZINE", "strength": "500 mg/1"}], "application_number": "ANDA210054", "marketing_category": "ANDA", "marketing_start_date": "20200819", "listing_expiration_date": "20261231"}