Primo APF

Product NDC
69509-054
11-digit product format
695090054
Labeler code
69509
Product ID
69509-054_d607ffd6-fb16-35ba-e053-2995a90abc1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
DENTAL
Labeler
Tri State Dental
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-09-01
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
6 g/454g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69509-054-152025-01-30C16284748780-12cef2736-82a1-d83d-e063-dadaa90ab31fc060aaef-d2e9-4acf-ac27-b30796239a8f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69509-054-15Primo APF454 g in 1 BOTTLE, PLASTICGEL4543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69509-054PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]3Legacy NDC, 1 package rows20220121_c060aaef-d2e9-4acf-ac27-b30796239a8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245593sodium fluoride 2 % Dental GelPSNc060aaef-d2e9-4acf-ac27-b30796239a8f3
245593sodium fluoride 0.02 MG/MG Oral GelSCDc060aaef-d2e9-4acf-ac27-b30796239a8f3
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSYc060aaef-d2e9-4acf-ac27-b30796239a8f3
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSYc060aaef-d2e9-4acf-ac27-b30796239a8f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69509-054-1569509005415454 g in 1 BOTTLE, PLASTIC (69509-054-15) 454 g2013-09-010000-00-00NoNoCurrent