NDC 70625-207

Ranolazine

Ranolazine

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

Product ID70625-207_052c5c05-95cf-44fc-bebc-60199d4cb2bb
NDC70625-207
Product TypeHuman Prescription Drug
Proprietary NameRanolazine
Generic NameRanolazine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA212781
Labeler NameSunGen Pharma LLC
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 70625-207-01

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70625-207-01)
Marketing Start Date2020-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70625-207-02 [70625020702]

Ranolazine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA212781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-01

NDC 70625-207-01 [70625020701]

Ranolazine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA212781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-01

Drug Details

Active Ingredients

IngredientStrength
RANOLAZINE1000 mg/1

OpenFDA Data

SPL SET ID:f3c09979-a44a-4197-97d2-29a207b6fc73
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616749
  • 728231
  • 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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