NDC 0781-8017

FLUVASTATIN SODIUM ER

Fluvastatin Sodium

FLUVASTATIN SODIUM ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Fluvastatin Sodium.

Product ID0781-8017_23218747-995f-4547-ba14-b2688b1f6bad
NDC0781-8017
Product TypeHuman Prescription Drug
Proprietary NameFLUVASTATIN SODIUM ER
Generic NameFluvastatin Sodium
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-10-16
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021192
Labeler NameSandoz Inc
Substance NameFLUVASTATIN SODIUM
Active Ingredient Strength80 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0781-8017-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-01)
Marketing Start Date2018-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-8017-01 [00781801701]

FLUVASTATIN SODIUM ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA021192
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-02

NDC 0781-8017-31 [00781801731]

FLUVASTATIN SODIUM ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA021192
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-02

Drug Details

Active Ingredients

IngredientStrength
FLUVASTATIN SODIUM80 mg/1

OpenFDA Data

SPL SET ID:5ab4296c-87c2-4c64-b218-d620eef51310
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 360507
    • UPC Code
  • 0307818017016

    • Pharmacological Class

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

    NDC Crossover Matching brand name "FLUVASTATIN SODIUM ER" 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
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