careone nicotine

Product NDC
41520-701
11-digit product format
415200701
Labeler code
41520
Product ID
41520-701_e1e056f5-68b5-43fc-b469-f6e130a9aec2
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
American Sales Company
Application
ANDA077007
Marketing category
ANDA
Marketing start
2006-03-07
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
careone 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
41520-701-05careone nicotine24 in 1 CONTAINERLOZENGE246
41520-701-05careone nicotine3 in 1 CARTONLOZENGE36

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-701CAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]6Current NDC, Legacy NDC, 2 package rows20231021_84ed0acf-dcd3-4d4a-8e5c-f75f48993b34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN84ed0acf-dcd3-4d4a-8e5c-f75f48993b346
359817nicotine 2 MG Oral LozengeSCD84ed0acf-dcd3-4d4a-8e5c-f75f48993b346
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY84ed0acf-dcd3-4d4a-8e5c-f75f48993b346
359817nicotine 2 MG TrocheSY84ed0acf-dcd3-4d4a-8e5c-f75f48993b346

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-701-05415200701053 CONTAINER in 1 CARTON (41520-701-05) / 24 LOZENGE in 1 CONTAINER3 container2009-11-060000-00-00NoNoCurrent