Nicotine

Product NDC
41250-424
11-digit product format
412500424
Labeler code
41250
Product ID
41250-424_42f8ad98-b92f-4381-9b22-2bafba3c31a8
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA090821
Marketing category
ANDA
Marketing start
2010-01-15
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Listing expiration
2027-12-31

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
41250-424-03Nicotine24 in 1 CONTAINERLOZENGE249
41250-424-05Nicotine3 in 1 CARTONLOZENGE39
41250-424-09Nicotine27 in 1 CONTAINERLOZENGE279
41250-424-10Nicotine4 in 1 CARTONLOZENGE49

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-424NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]7Current NDC, Legacy NDC, 4 package rows20250503_5bd02b68-84a2-43f1-9f01-fc4b8967e98a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN5bd02b68-84a2-43f1-9f01-fc4b8967e98a9
359818nicotine 4 MG Oral LozengeSCD5bd02b68-84a2-43f1-9f01-fc4b8967e98a9
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY5bd02b68-84a2-43f1-9f01-fc4b8967e98a9
359818nicotine 4 MG TrocheSY5bd02b68-84a2-43f1-9f01-fc4b8967e98a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-424-034125004240324 in 1 CONTAINERHistorical
41250-424-05412500424053 CONTAINER in 1 CARTON (41250-424-05) / 24 LOZENGE in 1 CONTAINER (41250-424-03) 3 container2010-01-150000-00-00NoNoCurrent
41250-424-094125004240927 in 1 CONTAINERHistorical
41250-424-10412500424104 CONTAINER in 1 CARTON (41250-424-10) / 27 LOZENGE in 1 CONTAINER (41250-424-09) 4 container2026-03-31NoNoHistorical