Nicotine

Product NDC
0363-0424
11-digit product format
003630424
Labeler code
0363
Product ID
0363-0424_25ffadb3-a5e9-41a8-b788-97604f6b65d5
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA090821
Marketing category
ANDA
Marketing start
2010-01-12
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
0363-0424-05Nicotine24 in 1 CONTAINERLOZENGE249
0363-0424-05Nicotine3 in 1 CARTONLOZENGE39
0363-0424-06Nicotine24 in 1 CONTAINERLOZENGE249
0363-0424-06Nicotine4 in 1 CARTONLOZENGE49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0424-05EA - Each0363-042488caf85e-2560-4948-93ae-50f00047dd9912014-08-01
0363-0424-06EA - Each0363-04248be87ab2-4d2c-4073-bf28-ea6ae78b438312022-06-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0424NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREEN COMPANY]9Current NDC, Legacy NDC, 4 package rows20230619_d2572335-9c54-4745-9a11-eb9b8d34d0cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNd2572335-9c54-4745-9a11-eb9b8d34d0cd9
359818nicotine 4 MG Oral LozengeSCDd2572335-9c54-4745-9a11-eb9b8d34d0cd9
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYd2572335-9c54-4745-9a11-eb9b8d34d0cd9
359818nicotine 4 MG TrocheSYd2572335-9c54-4745-9a11-eb9b8d34d0cd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0424-05003630424053 CONTAINER in 1 CARTON (0363-0424-05) / 24 LOZENGE in 1 CONTAINER3 container2010-01-120000-00-00NoNoCurrent
0363-0424-06003630424064 CONTAINER in 1 CARTON (0363-0424-06) > 24 LOZENGE in 1 CONTAINER4 container2010-04-140000-00-00NoNoCurrent