FDA.reportPublic FDA data

Nicotine

Product NDC
0363-0979
11-digit product format
003630979
Labeler code
0363
Product ID
0363-0979_c5269688-b2df-4261-a5df-fc9107a496f7
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreens
Application
ANDA210711
Marketing category
ANDA
Marketing start
2021-06-25
Marketing end
2027-02-25
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
0363-0979-27NicotineMini27 in 1 BOTTLE, PLASTICLOZENGE275
0363-0979-81NicotineMini27 in 1 BOTTLE, PLASTICLOZENGE275
0363-0979-81NicotineMini3 in 1 BOXLOZENGE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0979NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [WALGREENS]4Current NDC, Legacy NDC, 3 package rows20240223_2af56565-7e28-4915-ad60-49570c98a246.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN2af56565-7e28-4915-ad60-49570c98a2465
359818nicotine 4 MG Oral LozengeSCD2af56565-7e28-4915-ad60-49570c98a2465
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY2af56565-7e28-4915-ad60-49570c98a2465
359818nicotine 4 MG TrocheSY2af56565-7e28-4915-ad60-49570c98a2465

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0979-270036309792727 LOZENGE in 1 BOTTLE, PLASTIC (0363-0979-27) 27 lozenge2021-06-252027-02-25NoNoHistorical
0363-0979-81003630979813 BOTTLE, PLASTIC in 1 BOX (0363-0979-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC2021-06-252027-02-25NoNoCurrent