nicotine mini

Product NDC
0363-6011
11-digit product format
003636011
Labeler code
0363
Product ID
0363-6011_f244dac2-9c2c-42e4-88a5-3b2b1cfcb92f
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA203690
Marketing category
ANDA
Marketing start
2024-08-19
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nicotine mini
Listing expiration
2026-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6011-07nicotine mini3 in 1 CARTONLOZENGE32
0363-6011-09nicotine mini27 in 1 BOTTLELOZENGE272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6011NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [WALGREEN COMPANY]2Current NDC, 2 package rows20240828_4a08b910-5479-49f5-abbe-ca68949efb24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN4a08b910-5479-49f5-abbe-ca68949efb242
359818nicotine 4 MG Oral LozengeSCD4a08b910-5479-49f5-abbe-ca68949efb242
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY4a08b910-5479-49f5-abbe-ca68949efb242
359818nicotine 4 MG TrocheSY4a08b910-5479-49f5-abbe-ca68949efb242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-6011-07003636011073 BOTTLE in 1 CARTON (0363-6011-07) / 27 LOZENGE in 1 BOTTLE (0363-6011-09) 3 bottle2024-08-19NoNoHistorical
0363-6011-090036360110927 in 1 BOTTLEHistorical