NDC 54458-927

Pravastatin Sodium

Pravastatin Sodium

Pravastatin Sodium is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by International Laboratories, Llc. The primary component is Pravastatin Sodium.

Product ID54458-927_6316f531-a9e0-49a9-8a6a-fa29675217cb
NDC54458-927
Product TypeHuman Prescription Drug
Proprietary NamePravastatin Sodium
Generic NamePravastatin Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA076056
Labeler NameInternational Laboratories, LLC
Substance NamePRAVASTATIN SODIUM
Active Ingredient Strength10 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 54458-927-12

30 TABLET in 1 BLISTER PACK (54458-927-12)
Marketing Start Date2013-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54458-927-10 [54458092710]

Pravastatin Sodium TABLET
Marketing CategoryANDA
Application NumberANDA076056
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-02-09
Inactivation Date2020-01-31

NDC 54458-927-12 [54458092712]

Pravastatin Sodium TABLET
Marketing CategoryANDA
Application NumberANDA076056
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-26
Inactivation Date2020-01-31

NDC 54458-927-16 [54458092716]

Pravastatin Sodium TABLET
Marketing CategoryANDA
Application NumberANDA076056
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PRAVASTATIN SODIUM10 mg/1

OpenFDA Data

SPL SET ID:ad386ed4-a284-4da5-b79a-3c0f4165057a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904458
    • UPC Code
  • 0354458927168

    • Pharmacological Class

    • HMG-CoA Reductase Inhibitor [EPC]
    • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

    Medicade Reported Pricing

    54458092716 PRAVASTATIN SODIUM 10 MG TAB

    Pricing Unit: EA | Drug Type:

    54458092712 PRAVASTATIN SODIUM 10 MG TAB

    Pricing Unit: EA | Drug Type:

    54458092710 PRAVASTATIN SODIUM 10 MG TAB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Pravastatin Sodium" or generic name "Pravastatin Sodium"

    NDCBrand NameGeneric Name
    0093-0771Pravastatin SodiumPravastatin Sodium
    0093-7201Pravastatin SodiumPravastatin Sodium
    0093-7202Pravastatin SodiumPravastatin Sodium
    0093-7270Pravastatin SodiumPravastatin Sodium
    0615-6556Pravastatin SodiumPravastatin Sodium
    0615-6557Pravastatin SodiumPravastain Sodium
    0615-7740Pravastatin SodiumPravastatin Sodium
    0615-7868PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    0615-7869PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    0615-8029Pravastatin SodiumPravastatin Sodium
    0615-8030Pravastatin SodiumPravastatin Sodium
    68071-2088Pravastatin SodiumPravastatin Sodium
    68071-3247PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68071-3253pravastatin sodiumpravastatin sodium
    68071-1917Pravastatin sodiumPravastatin sodium
    68071-3358PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68071-3361PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68071-2194Pravastatin sodiumPravastatin sodium
    68071-3366PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68071-4039PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68071-4707pravastatin sodiumpravastatin sodium
    68180-488PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68180-487PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68180-486PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68180-485PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68382-071pravastatin sodiumpravastatin sodium
    68382-070pravastatin sodiumpravastatin sodium
    68382-073pravastatin sodiumpravastatin sodium
    68382-072pravastatin sodiumpravastatin sodium
    68462-195Pravastatin SodiumPravastatin Sodium
    68462-198Pravastatin SodiumPravastatin Sodium
    68462-197Pravastatin SodiumPravastatin Sodium
    68462-196Pravastatin SodiumPravastatin Sodium
    68788-7253PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68788-7013PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68788-7193Pravastatin sodiumPravastatin sodium
    68788-7316PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    68788-7413PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    69097-185Pravastatin SodiumPravastatin Sodium
    69097-186Pravastatin SodiumPravastatin Sodium
    69097-183Pravastatin SodiumPravastatin Sodium
    69097-184Pravastatin SodiumPravastatin Sodium
    70518-0304Pravastatin SodiumPravastatin Sodium
    70518-0412PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    70518-0549PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    70518-0707pravastatin sodiumpravastatin sodium
    70518-0423Pravastatin SodiumPravastatin Sodium
    70518-1197PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    70518-0936Pravastatin SodiumPravastatin Sodium
    70518-1710PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.