NDC 68983-006

iBrite

Sodium Fluoride, Potassium Nitrate

iBrite is a Oral Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Pac-dent International Inc.. The primary component is Sodium Fluoride; Potassium Nitrate.

• Product ID: 68983-006_25f0e453-ed77-141b-e054-00144ff8d46c
• NDC: 68983-006
• Product Type: Human Otc Drug
• Proprietary Name: iBrite
• Generic Name: Sodium Fluoride, Potassium Nitrate
• Dosage Form: Paste, Dentifrice
• Route of Administration: ORAL
• Marketing Start Date: 2016-02-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Pac-Dent International Inc.
• Substance Name: SODIUM FLUORIDE; POTASSIUM NITRATE
• Active Ingredient Strength: 3 mg/g; mg/g
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68983-006-04

1 TUBE in 1 CARTON (68983-006-04) > 25 g in 1 TUBE (68983-006-03)

• Marketing Start Date: 2016-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68983-006-03 [68983000603]

iBrite PASTE, DENTIFRICE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-02-01

NDC 68983-006-02 [68983000602]

iBrite PASTE, DENTIFRICE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-02-01
• Inactivation Date: 2020-01-31

NDC 68983-006-04 [68983000604]

iBrite PASTE, DENTIFRICE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-02-01
• Inactivation Date: 2020-01-31

NDC 68983-006-01 [68983000601]

iBrite PASTE, DENTIFRICE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-02-01

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	2.54 mg/g

OpenFDA Data

• SPL SET ID: 25f0e453-ed76-141b-e054-00144ff8d46c
• Manufacturer:
  • Pac-Dent International Inc.
• UNII:
  • RU45X2JN0Z
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 1734689

NDC Crossover Matching brand name "iBrite" or generic name "Sodium Fluoride, Potassium Nitrate"

NDC	Brand Name	Generic Name
68983-006	iBrite	Sodium Fluoride, Potassium Nitrate
53045-280	Ionite H	Sodium Fluoride, Potassium Nitrate
53045-281	Ionite H	Sodium Fluoride, Potassium Nitrate
61596-437	MIPaste	sodium fluoride, potassium nitrate