NDC 61958-1003

Ranexa

Ranolazine

Ranexa is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is Ranolazine.

Product ID61958-1003_4d2004e3-4c13-45fe-bf5a-92c7146691e8
NDC61958-1003
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 NameGilead Sciences, Inc.
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 Through2019-12-31

Packaging

NDC 61958-1003-1

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (61958-1003-1)
Marketing Start Date2006-01-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61958-1003-3 [61958100303]

Ranexa TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021526
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-01-27

NDC 61958-1003-2 [61958100302]

Ranexa TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021526
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-01-27

NDC 61958-1003-1 [61958100301]

Ranexa TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021526
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-01-27

Drug Details

Active Ingredients

IngredientStrength
RANOLAZINE500 mg/1

OpenFDA Data

SPL SET ID:beb482de-f251-476b-9d38-40577c36f5a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616749
  • 728231
  • 860738
  • 860737
  • 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]

    Medicade Reported Pricing

    61958100301 RANEXA ER 500 MG TABLET

    Pricing Unit: EA | Drug Type:

    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

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