ranolazine

Generic: ranolazine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ranolazine 1000 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-723
Product ID 50268-723_47fc05ed-b529-4ae7-e063-6394a90ae1dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209953
Listing Expiration 2027-12-31
Marketing Start 2022-09-20

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 50268723
Hyphenated Format 50268-723

Supplemental Identifiers

RxCUI
616749 728231
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 ANDA209953 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX (50268-723-13) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-723-11)
source: ndc

Packages (1)

50268-723-13 30 BLISTER PACK in 1 BOX (50268-723-13) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-723-11)

Ingredients (1)

ranolazine (1000 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": "47fc05ed-b529-4ae7-e063-6394a90ae1dd", "openfda": {"nui": ["N0000175427", "N0000190114", "N0000185503", "N0000182137", "N0000187061"], "unii": ["A6IEZ5M406"], "rxcui": ["616749", "728231"], "spl_set_id": ["e92350e8-5b0b-95d3-e053-2995a90a959b"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX (50268-723-13)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-723-11)", "package_ndc": "50268-723-13", "marketing_start_date": "20220920"}], "brand_name": "Ranolazine", "product_id": "50268-723_47fc05ed-b529-4ae7-e063-6394a90ae1dd", "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": "50268-723", "generic_name": "Ranolazine", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ranolazine", "active_ingredients": [{"name": "RANOLAZINE", "strength": "1000 mg/1"}], "application_number": "ANDA209953", "marketing_category": "ANDA", "marketing_start_date": "20220920", "listing_expiration_date": "20271231"}