Nicotine

Product NDC
0363-0411
11-digit product format
003630411
Labeler code
0363
Product ID
0363-0411_4aba8ee5-d2b0-4f6d-ba98-03fb96877c50
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA077007
Marketing category
ANDA
Marketing start
2006-02-23
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
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
0363-0411-05Nicotine3 in 1 CARTONLOZENGE38
0363-0411-05Nicotine24 in 1 CONTAINERLOZENGE248
0363-0411-06Nicotine24 in 1 CONTAINERLOZENGE248
0363-0411-06Nicotine4 in 1 CARTONLOZENGE48
0363-0411-10Nicotine4 in 1 CARTONLOZENGE48
0363-0411-10Nicotine27 in 1 CONTAINERLOZENGE278
0363-0411-16Nicotine6 in 1 CARTONLOZENGE68
0363-0411-16Nicotine24 in 1 CONTAINERLOZENGE248

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0411-05EA - Each0363-04113706e424-d873-469d-a988-d09350f732be12020-04-20
0363-0411-10EA - Each0363-041174db17d4-f36f-4237-860e-a7ecbabd3f9512023-06-06
0363-0411-16EA - Each0363-041121cdc1a9-8d82-4e79-bffa-ad13de3ae2cb12022-06-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0411NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREEN COMPANY]8Current NDC, Legacy NDC, 8 package rows20230505_1123afbb-1785-43f0-aca4-dd5a9565d774.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN1123afbb-1785-43f0-aca4-dd5a9565d7748
359817nicotine 2 MG Oral LozengeSCD1123afbb-1785-43f0-aca4-dd5a9565d7748
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY1123afbb-1785-43f0-aca4-dd5a9565d7748
359817nicotine 2 MG TrocheSY1123afbb-1785-43f0-aca4-dd5a9565d7748

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0411-05003630411053 CONTAINER in 1 CARTON (0363-0411-05) / 24 LOZENGE in 1 CONTAINER3 container2010-06-230000-00-00NoNoCurrent
0363-0411-06003630411064 CONTAINER in 1 CARTON (0363-0411-06) > 24 LOZENGE in 1 CONTAINER4 container2015-08-160000-00-00NoNoCurrent
0363-0411-10003630411104 CONTAINER in 1 CARTON (0363-0411-10) / 27 LOZENGE in 1 CONTAINER4 container2013-02-220000-00-00NoNoCurrent
0363-0411-16003630411166 CONTAINER in 1 CARTON (0363-0411-16) / 24 LOZENGE in 1 CONTAINER6 container2015-10-080000-00-00NoNoCurrent