FDA.reportPublic FDA data

nicotine

Product NDC
0363-1825
11-digit product format
003631825
Labeler code
0363
Product ID
0363-1825_ee4e4e2b-9f71-4e03-a214-ffcaa9e0e78e
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA203690
Marketing category
ANDA
Marketing start
2018-11-08
Substance
NICOTINE
Active strength
2 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
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817

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
0363-1825-07nicotine3 in 1 CARTONLOZENGE34
0363-1825-07nicotine27 in 1 CONTAINERLOZENGE274
0363-1825-09nicotine27 in 1 CONTAINERLOZENGE274
0363-1825-10nicotine4 in 1 CARTONLOZENGE44
0363-1825-10nicotine27 in 1 CONTAINERLOZENGE274
0363-1825-60nicotine1 in 1 CARTONLOZENGE14
0363-1825-60nicotine20 in 1 CONTAINERLOZENGE204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-1825-10EA - Each0363-182564a686e1-7fe0-443e-9e19-9e6f8a2b61ea12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1825NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREEN COMPANY]4Current NDC, Legacy NDC, 7 package rows20230603_8af06c23-80b7-4559-b594-a3a02297306d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN8af06c23-80b7-4559-b594-a3a02297306d4
359817nicotine 2 MG Oral LozengeSCD8af06c23-80b7-4559-b594-a3a02297306d4
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY8af06c23-80b7-4559-b594-a3a02297306d4
359817nicotine 2 MG TrocheSY8af06c23-80b7-4559-b594-a3a02297306d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1825-07003631825073 CONTAINER in 1 CARTON (0363-1825-07) / 27 LOZENGE in 1 CONTAINER3 container2018-11-080000-00-00NoNoCurrent
0363-1825-090036318250927 LOZENGE in 1 CONTAINER (0363-1825-09) 27 lozenge2018-11-08NoNoHistorical
0363-1825-10003631825104 CONTAINER in 1 CARTON (0363-1825-10) > 27 LOZENGE in 1 CONTAINER4 container2019-04-180000-00-00NoNoCurrent
0363-1825-60003631825601 CONTAINER in 1 CARTON (0363-1825-60) / 20 LOZENGE in 1 CONTAINER1 container2018-11-080000-00-00NoNoCurrent