FDA.reportPublic FDA data

Up and Up Mini Nicotine

Product NDC
82442-802
11-digit product format
824420802
Labeler code
82442
Product ID
82442-802_cee5ae38-56cf-4f88-b261-027903f93e83
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Target Corporation
Application
ANDA203690
Marketing category
ANDA
Marketing start
2024-05-20
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Up and Up Mini Nicotine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82442-802-07Up and Up Mini Nicotine3 in 1 CARTONLOZENGE33
82442-802-09Up and Up Mini Nicotine27 in 1 CONTAINERLOZENGE273
82442-802-10Up and Up Mini Nicotine4 in 1 CARTONLOZENGE43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82442-802UP AND UP MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]2Current NDC, 3 package rows20240522_a15b247e-cf4f-4802-a6e4-24750ea3809b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNa15b247e-cf4f-4802-a6e4-24750ea3809b3
359817nicotine 2 MG Oral LozengeSCDa15b247e-cf4f-4802-a6e4-24750ea3809b3
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYa15b247e-cf4f-4802-a6e4-24750ea3809b3
359817nicotine 2 MG TrocheSYa15b247e-cf4f-4802-a6e4-24750ea3809b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82442-802-07824420802073 CONTAINER in 1 CARTON (82442-802-07) / 27 LOZENGE in 1 CONTAINER (82442-802-09) 3 container2024-05-20NoNoHistorical
82442-802-098244208020927 in 1 CONTAINERHistorical
82442-802-10824420802104 CONTAINER in 1 CARTON (82442-802-10) / 27 LOZENGE in 1 CONTAINER (82442-802-09) 4 container2026-02-25NoNoHistorical