NDC 0378-8021

Fluvastatin Sodium

Fluvastatin

Fluvastatin Sodium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Fluvastatin Sodium.

Product ID0378-8021_48729b76-d32b-406e-b4b4-c95b7bea9978
NDC0378-8021
Product TypeHuman Prescription Drug
Proprietary NameFluvastatin Sodium
Generic NameFluvastatin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-03-19
Marketing CategoryANDA / ANDA
Application NumberANDA090595
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFLUVASTATIN SODIUM
Active Ingredient Strength40 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-8021-77

90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-77)
Marketing Start Date2013-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8021-10 [00378802110]

Fluvastatin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA090595
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-19
Marketing End Date2017-08-31

NDC 0378-8021-77 [00378802177]

Fluvastatin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA090595
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-03-19

NDC 0378-8021-93 [00378802193]

Fluvastatin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA090595
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-03-19

Drug Details

Active Ingredients

IngredientStrength
FLUVASTATIN SODIUM40 mg/1

OpenFDA Data

SPL SET ID:d0a7247c-5d83-4bc1-840f-c58314d14195
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310404
  • 310405

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.