NDC 29273-401

FloLipid

Simvastatin

FloLipid is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Salerno Pharmaceuticals Co.. The primary component is Simvastatin.

Product ID29273-401_37ec6157-4088-4638-8eba-74a6aa1238d3
NDC29273-401
Product TypeHuman Prescription Drug
Proprietary NameFloLipid
Generic NameSimvastatin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2017-11-01
Marketing CategoryNDA / NDA
Application NumberNDA206679
Labeler NameSalerno Pharmaceuticals Co.
Substance NameSIMVASTATIN
Active Ingredient Strength20 mg/5mL
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 29273-401-04

150 mL in 1 BOTTLE, GLASS (29273-401-04)
Marketing Start Date2017-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 29273-401-04 [29273040104]

FloLipid SUSPENSION
Marketing CategoryNDA
Application NumberNDA206679
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-01

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN20 mg/5mL

OpenFDA Data

SPL SET ID:6ee17d10-6eb1-452a-99e8-02381368b3fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1944262
  • 1790679
  • 1944264
  • 1944266
  • UPC Code
  • 0329273402046
  • 0329273401049
  • Pharmacological Class

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

    NDC Crossover Matching brand name "FloLipid" or generic name "Simvastatin"

    NDCBrand NameGeneric Name
    29273-402FloLipidFloLipid
    29273-401FloLipidFloLipid
    0093-7152SimvastatinSimvastatin
    0093-7153SimvastatinSimvastatin
    0093-7154SimvastatinSimvastatin
    0093-7155SimvastatinSimvastatin
    0093-7156SimvastatinSimvastatin
    0179-0128SimvastatinSimvastatin
    0179-0240simvastatinsimvastatin
    0179-0241simvastatinsimvastatin
    0179-0242simvastatinsimvastatin
    0179-0243simvastatinsimvastatin
    0179-1897SimvastatinSimvastatin
    0179-1898SimvastatinSimvastatin
    0179-1899SimvastatinSimvastatin
    0615-6579SimvastatinSimvastatin
    0615-6580SimvastatinSimvastatin
    0615-6581SimvastatinSimvastatin
    0615-6587SimvastatinSimvastatin
    0615-6588SimvastatinSimvastatin
    0615-7704SimvastatinSimvastatin
    0615-7705SimvastatinSimvastatin
    0615-7706SimvastatinSimvastatin
    0006-0543ZOCORSIMVASTATIN
    0006-0726ZOCORSIMVASTATIN
    0006-0735ZOCORSIMVASTATIN
    0006-0740ZOCORSIMVASTATIN
    0006-0749ZOCORSIMVASTATIN

    Trademark Results [FloLipid]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FLOLIPID
    FLOLIPID
    87537107 5504699 Live/Registered
    Salerno Pharmaceuticals LP
    2017-07-21

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