FDA.reportPublic FDA data

Mini Nicotine

Product NDC
0363-2640
11-digit product format
003632640
Labeler code
0363
Product ID
0363-2640_a566dae3-41b9-4ee7-8c4a-76ef0fedb757
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreens
Application
ANDA207868
Marketing category
ANDA
Marketing start
2019-09-01
Substance
NICOTINE
Active strength
4 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
Mini Nicotine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359818

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
0363-2640-08Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE279
0363-2640-08Mini Nicotine4 in 1 BOXLOZENGE49
0363-2640-20Mini Nicotine1 in 1 BOXLOZENGE19
0363-2640-20Mini Nicotine20 in 1 BOTTLE, PLASTICLOZENGE209
0363-2640-35Mini Nicotine5 in 1 BOXLOZENGE59
0363-2640-35Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE279
0363-2640-81Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE279
0363-2640-81Mini Nicotine3 in 1 BOXLOZENGE39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2640MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS]6Current NDC, Legacy NDC, 8 package rows20241109_dfdd100d-8808-40f4-a68e-1e0388be424d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNdfdd100d-8808-40f4-a68e-1e0388be424d9
359818nicotine 4 MG Oral LozengeSCDdfdd100d-8808-40f4-a68e-1e0388be424d9
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYdfdd100d-8808-40f4-a68e-1e0388be424d9
359818nicotine 4 MG TrocheSYdfdd100d-8808-40f4-a68e-1e0388be424d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-2640-08003632640084 BOTTLE, PLASTIC in 1 BOX (0363-2640-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC2019-09-01NoNoHistorical
0363-2640-20003632640201 BOTTLE, PLASTIC in 1 BOX (0363-2640-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC2019-09-01NoNoHistorical
0363-2640-35003632640355 BOTTLE, PLASTIC in 1 BOX (0363-2640-35) / 27 LOZENGE in 1 BOTTLE, PLASTIC2019-09-010000-00-00NoNoCurrent
0363-2640-81003632640813 BOTTLE, PLASTIC in 1 BOX (0363-2640-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC2019-09-010000-00-00NoNoCurrent