members mark nicotine

Product NDC
68196-084
11-digit product format
681960084
Labeler code
68196
Product ID
68196-084_a0f96342-bb41-486f-8266-8cdcf2c2225a
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
2020-08-05
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
members mark 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
68196-084-08members mark nicotine8 in 1 CARTONLOZENGE84
68196-084-09members mark nicotine27 in 1 CONTAINERLOZENGE274

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-084MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAM'S WEST INC]2Current NDC, Legacy NDC, 2 package rows20201007_d185b5e7-9bb1-4d16-b146-1fbfba874053.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNd185b5e7-9bb1-4d16-b146-1fbfba8740534
359818nicotine 4 MG Oral LozengeSCDd185b5e7-9bb1-4d16-b146-1fbfba8740534
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYd185b5e7-9bb1-4d16-b146-1fbfba8740534
359818nicotine 4 MG TrocheSYd185b5e7-9bb1-4d16-b146-1fbfba8740534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-084-08681960084088 CONTAINER in 1 CARTON (68196-084-08) / 27 LOZENGE in 1 CONTAINER (68196-084-09) 8 container2020-08-050000-00-00NoNoCurrent
68196-084-096819600840927 in 1 CONTAINERHistorical