nicotine

Product NDC
41250-190
11-digit product format
412500190
Labeler code
41250
Product ID
41250-190_9e89ae28-ac76-4d10-8ccd-455f14f9f64b
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA090711
Marketing category
ANDA
Marketing start
2009-09-16
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
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
41250-190-03nicotine24 in 1 CONTAINERLOZENGE249
41250-190-05nicotine3 in 1 CARTONLOZENGE39
41250-190-09nicotine27 in 1 CONTAINERLOZENGE279
41250-190-10nicotine4 in 1 CARTONLOZENGE49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41250-190-03EA - Each41250-1907cd6f94e-8740-4294-bf4b-955473e9af6112024-04-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-190NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]7Current NDC, Legacy NDC, 4 package rows20250425_18ee7d8b-7b18-404e-8e62-c10355bb0a26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN18ee7d8b-7b18-404e-8e62-c10355bb0a269
359818nicotine 4 MG Oral LozengeSCD18ee7d8b-7b18-404e-8e62-c10355bb0a269
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY18ee7d8b-7b18-404e-8e62-c10355bb0a269
359818nicotine 4 MG TrocheSY18ee7d8b-7b18-404e-8e62-c10355bb0a269

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-190-034125001900324 in 1 CONTAINERHistorical
41250-190-05412500190053 CONTAINER in 1 CARTON (41250-190-05) / 24 LOZENGE in 1 CONTAINER (41250-190-03) 3 container2009-09-160000-00-00NoNoCurrent
41250-190-094125001900927 in 1 CONTAINERHistorical
41250-190-10412500190104 CONTAINER in 1 CARTON (41250-190-10) / 27 LOZENGE in 1 CONTAINER (41250-190-09) 4 container2026-04-07NoNoHistorical