FDA.reportPublic FDA data

members mark Nicotine

Product NDC
68196-734
11-digit product format
681960734
Labeler code
68196
Product ID
68196-734_d1030380-60cd-48e8-994b-01c8751edf39
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Sam's West Inc
Application
ANDA203690
Marketing category
ANDA
Marketing start
2015-07-21
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
68196-734-01members mark Nicotine27 in 1 CONTAINERLOZENGE279
68196-734-06members mark Nicotine7 in 1 CARTONLOZENGE79
68196-734-06members mark Nicotine27 in 1 CONTAINERLOZENGE279
68196-734-07members mark Nicotine8 in 1 CARTONLOZENGE89

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-734MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAM'S WEST INC]8Current NDC, Legacy NDC, 4 package rows20241127_c31c30b9-7431-4b90-b011-f34e499df192.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNc31c30b9-7431-4b90-b011-f34e499df1929
359817nicotine 2 MG Oral LozengeSCDc31c30b9-7431-4b90-b011-f34e499df1929
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYc31c30b9-7431-4b90-b011-f34e499df1929
359817nicotine 2 MG TrocheSYc31c30b9-7431-4b90-b011-f34e499df1929

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-734-016819607340127 in 1 CONTAINERHistorical
68196-734-06681960734067 in 1 CARTONHistorical
68196-734-07681960734078 CONTAINER in 1 CARTON (68196-734-07) / 27 LOZENGE in 1 CONTAINER (68196-734-01) 8 container2020-02-240000-00-00NoNoCurrent