ionite apf

Generic: sodium fluoride

Labeler: dharma research, inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name ionite apf
Generic Name sodium fluoride
Labeler dharma research, inc.
Dosage Form GEL
Routes
DENTAL ORAL
Active Ingredients

sodium fluoride 10.241 g/490g

Manufacturer
Dharma Research, inc.

Identifiers & Regulatory

Product NDC 53045-201
Product ID 53045-201_205e68a0-f45e-4339-9eea-512e216e05ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2013-01-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53045201
Hyphenated Format 53045-201

Supplemental Identifiers

RxCUI
245593
UPC
0353045000239
UNII
8ZYQ1474W7

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ionite apf (source: ndc)
Generic Name sodium fluoride (source: ndc)
Routes
DENTAL ORAL
source: ndc

Resolved Composition

Strengths
  • 10.241 g/490g
source: ndc
Packaging
  • 245 g in 1 BOTTLE (53045-201-08)
  • 490 g in 1 BOTTLE (53045-201-17)
  • 3724 g in 1 BOTTLE (53045-201-38)
source: ndc

Packages (3)

53045-201-08 245 g in 1 BOTTLE (53045-201-08) 53045-201-17 490 g in 1 BOTTLE (53045-201-17) 53045-201-38 3724 g in 1 BOTTLE (53045-201-38)

Ingredients (1)

sodium fluoride (10.241 g/490g)

Linked Drug Pages (1)

Ionite APF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL", "ORAL"], "spl_id": "205e68a0-f45e-4339-9eea-512e216e05ae", "openfda": {"upc": ["0353045000239"], "unii": ["8ZYQ1474W7"], "rxcui": ["245593"], "spl_set_id": ["8ff1b377-0535-4548-a109-f9f1a43b85b7"], "manufacturer_name": ["Dharma Research, inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "245 g in 1 BOTTLE (53045-201-08)", "package_ndc": "53045-201-08", "marketing_start_date": "20130101"}, {"sample": false, "description": "490 g in 1 BOTTLE (53045-201-17)", "package_ndc": "53045-201-17", "marketing_start_date": "20130101"}, {"sample": false, "description": "3724 g in 1 BOTTLE (53045-201-38)", "package_ndc": "53045-201-38", "marketing_start_date": "20130101"}], "brand_name": "Ionite APF", "product_id": "53045-201_205e68a0-f45e-4339-9eea-512e216e05ae", "dosage_form": "GEL", "product_ndc": "53045-201", "generic_name": "Sodium Fluoride", "labeler_name": "Dharma Research, inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ionite APF", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "10.241 g/490g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20130101", "listing_expiration_date": "20261231"}