NDC 50228-423

RANOLAZINE

Ranolazine

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

Product ID50228-423_1b4bfe0a-14b8-4c82-84a0-f2efe05eaef0
NDC50228-423
Product TypeHuman Prescription Drug
Proprietary NameRANOLAZINE
Generic NameRanolazine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-06-04
Marketing CategoryANDA / ANDA
Application NumberANDA211829
Labeler NameScieGen Pharmaceuticals, 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 Through2020-12-31

Packaging

NDC 50228-423-05

500 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (50228-423-05)
Marketing Start Date2019-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50228-423-30 [50228042330]

RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211829
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-04

NDC 50228-423-60 [50228042360]

RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211829
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-04

NDC 50228-423-05 [50228042305]

RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211829
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-04

Drug Details

Active Ingredients

IngredientStrength
RANOLAZINE500 mg/1

OpenFDA Data

SPL SET ID:71d50258-75b7-4801-b0f4-c34fe883d57d
Manufacturer
UNII
UPC Code
  • 0350228424608
  • 0350228423304
  • 0350228423052
  • 0350228424059
  • 0350228423601
  • 0350228424301

    • 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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