NDC 0078-0354

Lescol XL

Fluvastatin Sodium

Lescol XL is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Fluvastatin Sodium.

Product ID0078-0354_04f77269-0504-4ffb-88cf-5834cfc6b173
NDC0078-0354
Product TypeHuman Prescription Drug
Proprietary NameLescol XL
Generic NameFluvastatin Sodium
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2000-10-06
Marketing CategoryNDA / NDA
Application NumberNDA021192
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameFLUVASTATIN SODIUM
Active Ingredient Strength80 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0078-0354-15

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0354-15)
Marketing Start Date2000-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0354-05 [00078035405]

Lescol XL TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021192
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-10-06

NDC 0078-0354-15 [00078035415]

Lescol XL TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021192
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-10-06

Drug Details

Active Ingredients

IngredientStrength
FLUVASTATIN SODIUM80 mg/1

OpenFDA Data

SPL SET ID:8a1823e7-26fb-4858-bac7-9e152e5ea16a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 687048
  • 360507
  • UPC Code
  • 0300780354059
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Lescol XL" or generic name "Fluvastatin Sodium"

    NDCBrand NameGeneric Name
    0093-7446Fluvastatin SodiumFluvastatin Sodium
    0527-2580Fluvastatin SodiumFluvastatin Sodium
    0781-5370FLUVASTATIN SODIUMfluvastatin sodium
    0781-8017FLUVASTATIN SODIUMfluvastatin sodium
    0078-0354Lescolfluvastatin sodium
    68151-4471Lescolfluvastatin sodium

    Trademark Results [Lescol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LESCOL
    LESCOL
    78542452 not registered Dead/Abandoned
    Novartis AG
    2005-01-05
    LESCOL
    LESCOL
    75315415 2171358 Dead/Cancelled
    NOVARTIS AG
    1997-06-26
    LESCOL
    LESCOL
    74067753 1639501 Live/Registered
    Sandoz Pharmaceuticals Corporation
    1990-06-08

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