ranolazine

Generic: ranolazine

Labeler: sungen pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ranolazine 1000 mg/1

Manufacturer
SunGen Pharma LLC

Identifiers & Regulatory

Product NDC 70625-207
Product ID 70625-207_49fc4d28-ef67-e6ac-e063-6394a90a0020
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212781
Listing Expiration 2027-12-31
Marketing Start 2020-04-01

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 70625207
Hyphenated Format 70625-207

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 ANDA212781 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70625-207-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70625-207-02)
source: ndc

Packages (2)

70625-207-01 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70625-207-01) 70625-207-02 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70625-207-02)

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": "49fc4d28-ef67-e6ac-e063-6394a90a0020", "openfda": {"nui": ["N0000175427", "N0000190114", "N0000185503", "N0000182137", "N0000187061"], "unii": ["A6IEZ5M406"], "rxcui": ["616749", "728231"], "spl_set_id": ["f3c09979-a44a-4197-97d2-29a207b6fc73"], "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": ["SunGen Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70625-207-01)", "package_ndc": "70625-207-01", "marketing_start_date": "20200401"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70625-207-02)", "package_ndc": "70625-207-02", "marketing_start_date": "20200401"}], "brand_name": "Ranolazine", "product_id": "70625-207_49fc4d28-ef67-e6ac-e063-6394a90a0020", "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": "70625-207", "generic_name": "RANOLAZINE", "labeler_name": "SunGen Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ranolazine", "active_ingredients": [{"name": "RANOLAZINE", "strength": "1000 mg/1"}], "application_number": "ANDA212781", "marketing_category": "ANDA", "marketing_start_date": "20200401", "listing_expiration_date": "20271231"}