Home NDC 53045-268 Avant
Product NDC 53045-268
11-digit product format 530450268
Labeler code 53045
Product ID 53045-268_78538c89-5afb-4316-a86a-1e5237d543e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride
Dosage form LIQUID
Route DENTAL
Labeler Dharma Research, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2021-01-22
Substance SODIUM FLUORIDE
Active strength 2 g/L
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Avant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 2 g/L
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 251960 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53045-268-64 Avant 1.9 L in 1 BOTTLE, PUMP LIQUID 1.9 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53045-268 AVANT (SODIUM FLUORIDE) LIQUID [DHARMA RESEARCH, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20210126_4749dce1-c0b9-4737-8a30-85cd58aba21b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Avant SODIUM FLUORIDE Dharma Research, Inc. 4749dce1-c0b9-4737-8a30-85cd58aba21b 2021-01-25 Warnings, Adverse reactions Exact identifier ndc (product): 53045-268
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53045-268-64 53045026864 1.9 L in 1 BOTTLE, PUMP (53045-268-64) 1.9 l 2021-01-22 0000-00-00 No No Current