Nicotine

Product NDC
0363-9620
11-digit product format
003639620
Labeler code
0363
Product ID
0363-9620_9eeb9062-7c01-47a9-87c7-330de72927be
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreens
Application
ANDA212056
Marketing category
ANDA
Marketing start
2021-01-31
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
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9620-24Nicotine24 in 1 BOTTLE, PLASTICLOZENGE246
0363-9620-24Nicotine1 in 1 BOXLOZENGE16
0363-9620-72Nicotine24 in 1 BOTTLE, PLASTICLOZENGE246
0363-9620-72Nicotine3 in 1 BOXLOZENGE36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9620NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS]6Current NDC, Legacy NDC, 4 package rows20221007_97ce52b1-d98e-4216-99c2-7e341c8fec43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN97ce52b1-d98e-4216-99c2-7e341c8fec436
359818nicotine 4 MG Oral LozengeSCD97ce52b1-d98e-4216-99c2-7e341c8fec436
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY97ce52b1-d98e-4216-99c2-7e341c8fec436
359818nicotine 4 MG TrocheSY97ce52b1-d98e-4216-99c2-7e341c8fec436

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9620-24003639620241 BOTTLE, PLASTIC in 1 BOX (0363-9620-24) / 24 LOZENGE in 1 BOTTLE, PLASTIC2021-01-310000-00-00NoNoCurrent
0363-9620-72003639620723 BOTTLE, PLASTIC in 1 BOX (0363-9620-72) / 24 LOZENGE in 1 BOTTLE, PLASTIC2021-01-310000-00-00NoNoCurrent