Nicotine

Product NDC
0363-5770
11-digit product format
003635770
Labeler code
0363
Product ID
0363-5770_faf865a9-e0b1-49ce-8e5b-2fc8ad581b72
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreens
Application
ANDA210711
Marketing category
ANDA
Marketing start
2021-08-20
Marketing end
2027-04-20
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Brand name suffix
Mini

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
0363-5770-20NicotineMini1 in 1 BOXLOZENGE16
0363-5770-20NicotineMini20 in 1 BOTTLE, PLASTICLOZENGE206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5770NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [WALGREENS]5Current NDC, Legacy NDC, 2 package rows20240224_06455f66-da8e-4be5-9069-6840f93d6d77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN06455f66-da8e-4be5-9069-6840f93d6d776
359818nicotine 4 MG Oral LozengeSCD06455f66-da8e-4be5-9069-6840f93d6d776
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY06455f66-da8e-4be5-9069-6840f93d6d776
359818nicotine 4 MG TrocheSY06455f66-da8e-4be5-9069-6840f93d6d776

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-5770-20003635770201 BOTTLE, PLASTIC in 1 BOX (0363-5770-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC2021-08-202027-04-20NoNoCurrent