NDC 72578-065

Ranolazine

Ranolazine

Ranolazine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Viona Pharmaceuticals Inc. The primary component is Ranolazine.

Product ID72578-065_743fe0ef-3a74-4e57-9e25-0f17ddfbbc81
NDC72578-065
Product TypeHuman Prescription Drug
Proprietary NameRanolazine
Generic NameRanolazine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-09-10
Marketing CategoryANDA / ANDA
Application NumberANDA210188
Labeler NameViona Pharmaceuticals Inc
Substance NameRANOLAZINE
Active Ingredient Strength1000 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 72578-065-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-01)
Marketing Start Date2019-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72578-065-01 [72578006501]

Ranolazine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210188
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-10

NDC 72578-065-14 [72578006514]

Ranolazine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210188
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-10

NDC 72578-065-30 [72578006530]

Ranolazine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210188
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-10

NDC 72578-065-05 [72578006505]

Ranolazine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210188
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-10

NDC 72578-065-77 [72578006577]

Ranolazine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210188
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-10

Drug Details

Active Ingredients

IngredientStrength
RANOLAZINE1000 mg/1

OpenFDA Data

SPL SET ID:00979fb3-d70f-493d-94ca-2914cbadaa9d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616749
  • 728231
    • UPC Code
  • 0372578065140

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

    NDCBrand NameGeneric Name
    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
    68180-355RANOLAZINERANOLAZINE
    68180-354RANOLAZINERANOLAZINE
    63304-017RanolazineRanolazine
    63304-018RanolazineRanolazine
    69097-222RanolazineRanolazine
    69097-221RanolazineRanolazine
    51407-226RANOLAZINERANOLAZINE
    51407-225RANOLAZINERANOLAZINE
    68462-319RanolazineRanolazine
    68462-320RanolazineRanolazine
    71610-322RANOLAZINERANOLAZINE
    72578-065RanolazineRanolazine
    72578-064RanolazineRanolazine
    70771-1500RanolazineRanolazine
    70771-1499RanolazineRanolazine
    47335-624ASPRUZYO SPRINKLERanolazine
    47335-625ASPRUZYO SPRINKLERanolazine
    43353-880RanexaRANOLAZINE
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