NDC 43353-880

Ranexa

Ranolazine

Ranexa is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Ranolazine.

Product ID43353-880_d39e6df1-44b6-46a3-9da7-250f6a589b01
NDC43353-880
Product TypeHuman Prescription Drug
Proprietary NameRanexa
Generic NameRanolazine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2006-01-27
Marketing CategoryNDA / NDA
Application NumberNDA021526
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameRANOLAZINE
Active Ingredient Strength500 mg/1
Pharm ClassesAnti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-880-83

3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-880-83)
Marketing Start Date2016-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-880-83 [43353088083]

Ranexa TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021526
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-06

Drug Details

Active Ingredients

IngredientStrength
RANOLAZINE500 mg/1

OpenFDA Data

SPL SET ID:4299062a-b208-4e08-93ec-a05894541c07
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616749
  • 860738

    • Pharmacological Class

    • Anti-anginal [EPC]
    • Cytochrome P450 3A Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Organic Cation Transporter 2 Inhibitors [MoA]
    • Anti-anginal [EPC]
    • Cytochrome P450 3A Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Organic Cation Transporter 2 Inhibitors [MoA]

    NDC Crossover Matching brand name "Ranexa" or generic name "Ranolazine"

    NDCBrand NameGeneric Name
    43353-880RanexaRANOLAZINE
    68151-5004RanexaRanexa
    61958-1003RanexaRanexa
    61958-1001RanexaRanexa
    61958-1004RanexaRanexa
    61958-1002RanexaRanexa
    47335-624ASPRUZYO SPRINKLERanolazine
    47335-625ASPRUZYO SPRINKLERanolazine
    27241-125RanolazineRanolazine
    27241-126RanolazineRanolazine
    31722-668RanolazineRanolazine
    31722-669RanolazineRanolazine
    42291-773RanolazineRANOLAZINE
    42291-774RanolazineRANOLAZINE
    42385-963RanolazineRanolazine
    42385-964RanolazineRanolazine
    42571-324RanolazineRanolazine
    42571-325RanolazineRanolazine
    43975-289RanolazineRanolazine
    43975-290RanolazineRanolazine
    45963-418RanolazineRanolazine
    45963-419RanolazineRanolazine
    48792-7893RANOLAZINEranolazine
    48792-7894RANOLAZINEranolazine
    50228-423RANOLAZINERANOLAZINE
    50228-424RANOLAZINERANOLAZINE
    50268-722RanolazineRanolazine

    Trademark Results [Ranexa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RANEXA
    RANEXA
    86723196 5163874 Live/Registered
    Gilead Sciences, Inc.
    2015-08-12
    RANEXA
    RANEXA
    78397268 3094007 Live/Registered
    GILEAD SCIENCES, INC.
    2004-04-06
    RANEXA
    RANEXA
    78051432 not registered Dead/Abandoned
    CV Therapeutics, Inc.
    2001-03-05
    RANEXA
    RANEXA
    77489909 3944703 Live/Registered
    GILEAD SCIENCES, INC.
    2008-06-03
    RANEXA
    RANEXA
    77112751 not registered Dead/Abandoned
    GILEAD PALO ALTO, INC.
    2007-02-21
    RANEXA
    RANEXA
    76978127 3117797 Dead/Cancelled
    GILEAD SCIENCES, INC.
    2003-11-19
    RANEXA
    RANEXA
    76560883 not registered Dead/Abandoned
    CV Therapeutics
    2003-11-19
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.