FDA.reportPublic FDA data

members mark nicotine

Product NDC
68196-082
11-digit product format
681960082
Labeler code
68196
Product ID
68196-082_4f7bd0c2-296a-496f-b6d1-87dd884d8a72
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Sam's West Inc
Application
ANDA077007
Marketing category
ANDA
Marketing start
2015-07-29
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
members mark 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
68196-082-09members mark nicotine27 in 1 CONTAINERLOZENGE276
68196-082-13members mark nicotine7 in 1 PACKAGELOZENGE76
68196-082-14members mark nicotine8 in 1 PACKAGELOZENGE86

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-082MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAM'S WEST INC]5Current NDC, Legacy NDC, 3 package rows20200605_78126814-286e-485f-a4ce-77587f3d77e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN78126814-286e-485f-a4ce-77587f3d77e36
359817nicotine 2 MG Oral LozengeSCD78126814-286e-485f-a4ce-77587f3d77e36
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY78126814-286e-485f-a4ce-77587f3d77e36
359817nicotine 2 MG TrocheSY78126814-286e-485f-a4ce-77587f3d77e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-082-096819600820927 LOZENGE in 1 CONTAINER (68196-082-09) 27 lozenge2015-07-290000-00-00NoNoCurrent
68196-082-13681960082137 CONTAINER in 1 PACKAGE (68196-082-13) > 27 LOZENGE in 1 CONTAINER7 container2015-07-290000-00-00NoNoCurrent
68196-082-14681960082148 CONTAINER in 1 PACKAGE (68196-082-14) / 27 LOZENGE in 1 CONTAINER (68196-082-09) 8 container2019-04-170000-00-00NoNoCurrent