Nicotine

Product NDC
41250-957
11-digit product format
412500957
Labeler code
41250
Product ID
41250-957_c0f1a0c4-802c-447a-abc9-66c6498919b3
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA203690
Marketing category
ANDA
Marketing start
2013-01-18
Substance
NICOTINE
Active strength
4 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
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
41250-957-02Nicotine27 in 1 CONTAINERLOZENGE274
41250-957-02Nicotine3 in 1 CARTONLOZENGE34
41250-957-60Nicotine20 in 1 CONTAINERLOZENGE204
41250-957-60Nicotine1 in 1 CARTONLOZENGE14

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-957NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]4Current NDC, Legacy NDC, 4 package rows20190426_dc70703e-2c55-4178-a5d5-50f762ab6492.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNdc70703e-2c55-4178-a5d5-50f762ab64924
359818nicotine 4 MG Oral LozengeSCDdc70703e-2c55-4178-a5d5-50f762ab64924
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYdc70703e-2c55-4178-a5d5-50f762ab64924
359818nicotine 4 MG TrocheSYdc70703e-2c55-4178-a5d5-50f762ab64924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-957-02412500957023 CONTAINER in 1 CARTON (41250-957-02) / 27 LOZENGE in 1 CONTAINER3 container2013-01-180000-00-00NoNoCurrent
41250-957-60412500957601 CONTAINER in 1 CARTON (41250-957-60) / 20 LOZENGE in 1 CONTAINER1 container2019-04-240000-00-00NoNoCurrent