NDC 0003-5194

PRAVACHOL

Pravastatin Sodium

PRAVACHOL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Pravastatin Sodium.

Product ID0003-5194_734f03a0-0af0-4d60-97e7-c43ad52b57c2
NDC0003-5194
Product TypeHuman Prescription Drug
Proprietary NamePRAVACHOL
Generic NamePravastatin Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-06-01
Marketing CategoryNDA / NDA
Application NumberNDA019898
Labeler NameE.R. Squibb & Sons, L.L.C.
Substance NamePRAVASTATIN SODIUM
Active Ingredient Strength40 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0003-5194-10

90 TABLET in 1 BOTTLE (0003-5194-10)
Marketing Start Date2009-06-01
Marketing End Date2021-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0003-5194-10 [00003519410]

PRAVACHOL TABLET
Marketing CategoryNDA
Application NumberNDA019898
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-01
Marketing End Date2021-10-31

Drug Details

Active Ingredients

IngredientStrength
PRAVASTATIN SODIUM40 mg/1

OpenFDA Data

SPL SET ID:897ad8b7-921d-eb02-a61c-3419e662a2da
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904475
  • 904477
  • 904467
  • 904469
  • 904481
  • 904483
    • UPC Code
  • 0300000000001

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0003-5178PRAVACHOLPRAVASTATIN SODIUM
    0003-5194PRAVACHOLPRAVASTATIN SODIUM
    0003-5195PRAVACHOLPRAVASTATIN SODIUM
    0615-7570PravastatinPravastatin Sodium
    0093-0771Pravastatin SodiumPravastatin Sodium
    0093-7201Pravastatin SodiumPravastatin Sodium
    0093-7202Pravastatin SodiumPravastatin Sodium
    0093-7270Pravastatin SodiumPravastatin Sodium
    0615-6556Pravastatin SodiumPravastatin Sodium
    0615-7740Pravastatin SodiumPravastatin Sodium
    0615-7868PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    0615-7869PRAVASTATIN SODIUMPRAVASTATIN SODIUM
    0615-8029Pravastatin SodiumPravastatin Sodium
    0615-8030Pravastatin SodiumPravastatin Sodium

    Trademark Results [PRAVACHOL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRAVACHOL
    PRAVACHOL
    74105496 1726619 Dead/Cancelled
    E. R. Squibb & Sons, Inc.
    1990-10-12
    PRAVACHOL
    PRAVACHOL
    73703835 1498284 Live/Registered
    E. R. SQUIBB & SONS, INC.
    1988-01-04
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.