NDC 53045-205

Ionite APF

Sodium Fluoride

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

Product ID53045-205_16feddba-f871-4445-a788-904bafb375be
NDC53045-205
Product TypeHuman Prescription Drug
Proprietary NameIonite APF
Generic NameSodium Fluoride
Dosage FormGel
Route of AdministrationDENTAL; ORAL; TOPICAL
Marketing Start Date2013-01-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameDharma Research, inc.
Substance NameSODIUM FLUORIDE
Active Ingredient Strength6 g/490g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53045-205-17

490 g in 1 BOTTLE (53045-205-17)
Marketing Start Date2013-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53045-205-17 [53045020517]

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 FLUORIDE6.027 g/490g

OpenFDA Data

SPL SET ID:ab9b07ad-f6b2-4289-bec4-fec58270dc97
Manufacturer
UNII

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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