NDC 53045-201

Ionite APF

Sodium Fluoride

Ionite APF is a Dental; Oral Gel in the Human Prescription Drug category. It is labeled and distributed by Dharma Research, Inc.. The primary component is Sodium Fluoride.

Product ID53045-201_205e68a0-f45e-4339-9eea-512e216e05ae
NDC53045-201
Product TypeHuman Prescription Drug
Proprietary NameIonite APF
Generic NameSodium Fluoride
Dosage FormGel
Route of AdministrationDENTAL; ORAL
Marketing Start Date2013-01-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameDharma Research, inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength10 g/490g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53045-201-08

245 g in 1 BOTTLE (53045-201-08)
Marketing Start Date2013-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53045-201-17 [53045020117]

Ionite APF GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-01
Inactivation Date2020-01-31

NDC 53045-201-08 [53045020108]

Ionite APF GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE10.241 g/490g

OpenFDA Data

SPL SET ID:8ff1b377-0535-4548-a109-f9f1a43b85b7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 245593

    • NDC Crossover Matching brand name "Ionite APF" or generic name "Sodium Fluoride"

    NDCBrand NameGeneric Name
    53045-204Ionite APFIonite APF
    53045-200Ionite APFIonite APF
    53045-201Ionite APFIonite APF
    53045-205Ionite APFIonite APF
    53045-206Ionite APFIonite APF
    53045-203Ionite APFIonite APF
    53045-202Ionite APFIonite APF
    53045-207Ionite APFIonite APF
    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
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