NDC 63304-018

Ranolazine

Ranolazine

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

Product ID63304-018_5a1c31b6-346d-47c8-b531-a2414c3dd52d
NDC63304-018
Product TypeHuman Prescription Drug
Proprietary NameRanolazine
Generic NameRanolazine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA211707
Labeler NameSun Pharmaceutical Industries, 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 Through2021-12-31

Packaging

NDC 63304-018-05

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-018-05)
Marketing Start Date2019-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63304-018-28 [63304001828]

Ranolazine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211707
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-28

NDC 63304-018-60 [63304001860]

Ranolazine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211707
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-28

NDC 63304-018-05 [63304001805]

Ranolazine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211707
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-28

Drug Details

Active Ingredients

IngredientStrength
RANOLAZINE1000 mg/1

OpenFDA Data

SPL SET ID:c5848232-b7fd-4fe5-a543-16d6c4b5c0b1
Manufacturer
UNII
UPC Code
  • 0363304017601
  • 0363304018608

    • 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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