NDC 44946-1016

Ludent

Sodium Fluoride

Ludent is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Sancilio & Company Inc. The primary component is Sodium Fluoride.

Product ID44946-1016_3424acc5-d8d6-4d35-b83e-f89323bbc289
NDC44946-1016
Product TypeHuman Prescription Drug
Proprietary NameLudent
Generic NameSodium Fluoride
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2009-09-10
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameSancilio & Company Inc
Substance NameSODIUM FLUORIDE
Active Ingredient Strength1 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 44946-1016-7

7 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1016-7)
Marketing Start Date2009-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 44946-1016-6 [44946101606]

Ludent TABLET, CHEWABLE
Marketing CategoryUnapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-10
Inactivation Date2019-10-21

NDC 44946-1016-7 [44946101607]

Ludent TABLET, CHEWABLE
Marketing CategoryUnapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-10
Inactivation Date2019-10-21

NDC 44946-1016-2 [44946101602]

Ludent TABLET, CHEWABLE
Marketing CategoryUnapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-10
Inactivation Date2019-10-21

NDC 44946-1016-3 [44946101603]

Ludent TABLET, CHEWABLE
Marketing CategoryUnapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-10
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE.5 mg/1

OpenFDA Data

SPL SET ID:6e7a7e17-7538-4763-810c-7e56bd630494
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198215
  • 313036
  • 901288
  • 901280
  • 901296
  • 315213
    • UPC Code
  • 0344946101736

    • NDC Crossover Matching brand name "Ludent" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    44946-1016LudentLudent
    44946-1017LudentLudent
    44946-1015LudentLudent
    0135-0234AQUAFRESHsodium fluoride
    0126-0021ColgateSODIUM FLUORIDE
    0126-0034Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape FluorideSODIUM FLUORIDE
    0126-0032Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint FluorideSODIUM FLUORIDE
    0041-1421Oral-BSodium Fluoride
    0126-0131Phos-FlurSodium Fluoride
    0126-0135Phos-Flur Ortho DefenseSODIUM FLUORIDE
    0126-0138Phos-Flur Ortho DefenseSODIUM FLUORIDE
    0126-0139Phos-Flur Ortho DefenseSODIUM FLUORIDE
    0126-0074PrevidDent 5000 Booster Plus SpearmintSodium Fluoride
    0126-0016PreviDentSodium fluoride
    0126-0075PreviDentSodium fluoride
    0126-0076PreviDentSodium fluoride
    0126-0179PreviDentSodium Fluoride
    0126-0286PreviDentSodium Fluoride
    0126-0287PreviDentSodium Fluoride
    0126-0072PreviDent 5000 Booster Plus FruitasticSodium Fluoride
    0126-0033PreviDent Alcohol FreeSodium Fluoride
    0126-0088PreviDent Fresh MintSodium Fluoride
    0126-0289PreviDent OrthoDefenseSODIUM FLUORIDE
    0126-0288PreviDent Very BerrySodium Fluoride

    Trademark Results [Ludent]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LUDENT
    LUDENT
    98004788 not registered Live/Pending
    Luvantix ADM Co., Ltd.
    2023-05-19
    LUDENT
    LUDENT
    98004788 not registered Live/Pending
    3DMaterials Co., Ltd.
    2023-05-19
    LUDENT
    LUDENT
    77865700 3869394 Live/Registered
    MICELLE BIOPHARMA, INC.
    2009-11-05
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.