nicotine

Product NDC
0363-0201
11-digit product format
003630201
Labeler code
0363
Product ID
0363-0201_1ff2efe9-ead6-4823-b419-c333310063e1
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
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
0363-0201-03nicotine24 in 1 CONTAINERLOZENGE249
0363-0201-05nicotine3 in 1 CARTONLOZENGE39
0363-0201-06nicotine4 in 1 CARTONLOZENGE49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0201-05EA - Each0363-0201612d0c05-dc03-4f8a-9d0d-402ef7e86e6912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0201NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREEN COMPANY]8Current NDC, Legacy NDC, 3 package rows20230601_b1154b04-b3a6-4af9-a933-486c5501d46e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNb1154b04-b3a6-4af9-a933-486c5501d46e9
359817nicotine 2 MG Oral LozengeSCDb1154b04-b3a6-4af9-a933-486c5501d46e9
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYb1154b04-b3a6-4af9-a933-486c5501d46e9
359817nicotine 2 MG TrocheSYb1154b04-b3a6-4af9-a933-486c5501d46e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0201-030036302010324 in 1 CONTAINERHistorical
0363-0201-05003630201053 CONTAINER in 1 CARTON (0363-0201-05) / 24 LOZENGE in 1 CONTAINER (0363-0201-03) 3 container2010-01-120000-00-00NoNoCurrent
0363-0201-06003630201064 CONTAINER in 1 CARTON (0363-0201-06) > 24 LOZENGE in 1 CONTAINER4 container2010-04-140000-00-00NoNoCurrent