nicotine

Product NDC
0363-0124
11-digit product format
003630124
Labeler code
0363
Product ID
0363-0124_0ba190cf-8759-426e-aad1-9a9429c80842
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA090711
Marketing category
ANDA
Marketing start
2009-09-15
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
0363-0124-03nicotine24 in 1 CONTAINERLOZENGE248
0363-0124-05nicotine3 in 1 CARTONLOZENGE38
0363-0124-06nicotine4 in 1 CARTONLOZENGE48
0363-0124-09nicotine27 in 1 CONTAINERLOZENGE278
0363-0124-10nicotine4 in 1 CARTONLOZENGE48

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0124-05EA - Each0363-01244a5a358c-2a31-4aa1-818e-1fdc3f326f3e12021-06-02
0363-0124-06EA - Each0363-01247179a49f-42b7-4ae6-b922-8c0a7a7c773212018-08-13
0363-0124-10EA - Each0363-0124e8affff3-f022-4cfe-b402-f35e5dac2f6012020-04-20

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0124NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREEN COMPANY]8Current NDC, Legacy NDC, 5 package rows20250322_4a81d378-009d-43a9-a895-e371ffa700e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN4a81d378-009d-43a9-a895-e371ffa700e98
359817nicotine 2 MG Oral LozengeSCD4a81d378-009d-43a9-a895-e371ffa700e98
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY4a81d378-009d-43a9-a895-e371ffa700e98
359817nicotine 2 MG TrocheSY4a81d378-009d-43a9-a895-e371ffa700e98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0124-030036301240324 in 1 CONTAINERHistorical
0363-0124-05003630124053 CONTAINER in 1 CARTON (0363-0124-05) / 24 LOZENGE in 1 CONTAINER (0363-0124-03) 3 container2009-09-150000-00-00NoNoCurrent
0363-0124-06003630124064 CONTAINER in 1 CARTON (0363-0124-06) > 24 LOZENGE in 1 CONTAINER4 container2009-11-040000-00-00NoNoCurrent
0363-0124-090036301240927 in 1 CONTAINERHistorical
0363-0124-10003630124104 CONTAINER in 1 CARTON (0363-0124-10) / 27 LOZENGE in 1 CONTAINER (0363-0124-09) 4 container2009-09-160000-00-00NoNoCurrent