FDA.reportPublic FDA data

Members Mark Nicotine

Product NDC
68196-873
11-digit product format
681960873
Labeler code
68196
Product ID
68196-873_c5eb8d6d-612e-46e8-9474-ccb77fda256d
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
2007-09-07
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-873-09Members Mark Nicotine27 in 1 CONTAINERLOZENGE277
68196-873-13Members Mark Nicotine7 in 1 PACKAGELOZENGE77
68196-873-14Members Mark Nicotine8 in 1 PACKAGELOZENGE87

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-873MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAM'S WEST INC]6Current NDC, Legacy NDC, 3 package rows20200708_36c15917-eceb-4f5a-9021-711956e7b51b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN36c15917-eceb-4f5a-9021-711956e7b51b7
359818nicotine 4 MG Oral LozengeSCD36c15917-eceb-4f5a-9021-711956e7b51b7
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY36c15917-eceb-4f5a-9021-711956e7b51b7
359818nicotine 4 MG TrocheSY36c15917-eceb-4f5a-9021-711956e7b51b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-873-096819608730927 in 1 CONTAINERHistorical
68196-873-13681960873137 CONTAINER in 1 PACKAGE (68196-873-13) > 27 LOZENGE in 1 CONTAINER (68196-873-09) 7 container2015-07-280000-00-00NoNoCurrent
68196-873-14681960873148 CONTAINER in 1 PACKAGE (68196-873-14) / 27 LOZENGE in 1 CONTAINER (68196-873-09) 8 container2019-02-040000-00-00NoNoCurrent