NDC 53045-265

Ionite R

Sodium Fluoride

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

Product ID53045-265_892f5bdc-eabb-4942-925e-93164f9fc826
NDC53045-265
Product TypeHuman Prescription Drug
Proprietary NameIonite R
Generic NameSodium Fluoride
Dosage FormLiquid
Route of AdministrationDENTAL; ORAL
Marketing Start Date2013-11-03
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameDharma Research, Inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength38 g/L
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53045-265-64

1.9 L in 1 BOTTLE, PUMP (53045-265-64)
Marketing Start Date2013-11-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53045-265-64 [53045026564]

Ionite R LIQUID
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-11-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE38 g/L

OpenFDA Data

SPL SET ID:0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 251960

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

    NDCBrand NameGeneric Name
    53045-265Ionite RIonite R
    53045-266Ionite RIonite R
    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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