NDC 45963-418

Ranolazine

Ranolazine

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

Product ID45963-418_010629e0-0ffa-4f94-a5b9-dd6d9bd43721
NDC45963-418
Product TypeHuman Prescription Drug
Proprietary NameRanolazine
Generic NameRanolazine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA208862
Labeler NameActavis Pharma, 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 Through2021-12-31

Packaging

NDC 45963-418-06

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-418-06)
Marketing Start Date2019-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-418-06 [45963041806]

Ranolazine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-28

NDC 45963-418-50 [45963041850]

Ranolazine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-28

Drug Details

Active Ingredients

IngredientStrength
RANOLAZINE500 mg/1

OpenFDA Data

SPL SET ID:896ea7ab-8714-4e8b-a194-5b0bde318032
Manufacturer
UNII
UPC Code
  • 0345963418067
  • 0345963419064
  • 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]

    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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