ranolazine

Generic: ranolazine

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ranolazine
Generic Name ranolazine
Labeler viona pharmaceuticals inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ranolazine 1000 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-065
Product ID 72578-065_ca6a476b-e330-4618-8661-08ac1125fc3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210188
Listing Expiration 2027-12-31
Marketing Start 2019-09-10

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 72578065
Hyphenated Format 72578-065

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 ANDA210188 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-05)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-14)
  • 10 BLISTER PACK in 1 CARTON (72578-065-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (72578-065-30)
source: ndc

Packages (4)

72578-065-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-01) 72578-065-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-05) 72578-065-14 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-14) 72578-065-77 10 BLISTER PACK in 1 CARTON (72578-065-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (72578-065-30)

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": "ca6a476b-e330-4618-8661-08ac1125fc3e", "openfda": {"nui": ["N0000175427", "N0000190114", "N0000185503", "N0000182137", "N0000187061"], "unii": ["A6IEZ5M406"], "rxcui": ["616749", "728231"], "spl_set_id": ["00979fb3-d70f-493d-94ca-2914cbadaa9d"], "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": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-01)", "package_ndc": "72578-065-01", "marketing_start_date": "20190910"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-05)", "package_ndc": "72578-065-05", "marketing_start_date": "20190910"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-14)", "package_ndc": "72578-065-14", "marketing_start_date": "20190910"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (72578-065-77)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (72578-065-30)", "package_ndc": "72578-065-77", "marketing_start_date": "20190910"}], "brand_name": "Ranolazine", "product_id": "72578-065_ca6a476b-e330-4618-8661-08ac1125fc3e", "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": "72578-065", "generic_name": "Ranolazine", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ranolazine", "active_ingredients": [{"name": "RANOLAZINE", "strength": "1000 mg/1"}], "application_number": "ANDA210188", "marketing_category": "ANDA", "marketing_start_date": "20190910", "listing_expiration_date": "20271231"}