NDC 0378-5121

Fluvastatin Sodium

Fluvastatin

Fluvastatin Sodium is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Fluvastatin Sodium.

Product ID0378-5121_385f9f12-0e8d-459d-a83c-56b9fb5892cc
NDC0378-5121
Product TypeHuman Prescription Drug
Proprietary NameFluvastatin Sodium
Generic NameFluvastatin
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-09-11
Marketing End Date2019-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA202458
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFLUVASTATIN SODIUM
Active Ingredient Strength80 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 0378-5121-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5121-01)
Marketing Start Date2015-09-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5121-01 [00378512101]

Fluvastatin Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202458
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-11
Marketing End Date2019-07-31

NDC 0378-5121-05 [00378512105]

Fluvastatin Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202458
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-11
Marketing End Date2017-09-01

NDC 0378-5121-93 [00378512193]

Fluvastatin Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202458
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-11
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
FLUVASTATIN SODIUM80 mg/1

OpenFDA Data

SPL SET ID:4226222a-7729-42aa-8dff-887491a5dab7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 360507

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-7446Fluvastatin SodiumFluvastatin Sodium
    0378-5121Fluvastatin Sodiumfluvastatin
    0378-8020Fluvastatin Sodiumfluvastatin
    0378-8021Fluvastatin Sodiumfluvastatin
    0527-2580Fluvastatin SodiumFluvastatin Sodium
    0781-5370FLUVASTATIN SODIUMfluvastatin sodium
    0781-8017FLUVASTATIN SODIUMfluvastatin sodium
    68151-1326Fluvastatin Sodiumfluvastatin
    68151-1334Fluvastatin Sodiumfluvastatin
    0093-7442FluvastatinFluvastatin
    0093-7443FluvastatinFluvastatin
    63629-8737FluvastatinFluvastatin
    63629-8812FluvastatinFluvastatin
    0078-0354Lescolfluvastatin sodium
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