FDA.reportPublic FDA data

members mark nicotine

Product NDC
68196-309
11-digit product format
681960309
Labeler code
68196
Product ID
68196-309_a4e2ee92-66a7-4cba-91d9-2eb30ef5acfa
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Sam's West Inc
Application
ANDA206393
Marketing category
ANDA
Marketing start
2017-04-05
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
Rxcui311975

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
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
68196-309-25members mark nicotine110 in 1 CARTONGUM, CHEWING1106
68196-309-25members mark nicotine1 in 1 BLISTER PACKGUM, CHEWING16
68196-309-29members mark nicotine110 in 1 CARTONGUM, CHEWING1106
68196-309-29members mark nicotine2 in 1 CARTONGUM, CHEWING26
68196-309-30members mark nicotine1 in 1 BLISTER PACKGUM, CHEWING16
68196-309-30members mark nicotine300 in 1 CARTONGUM, CHEWING3006
68196-309-47members mark nicotine150 in 1 CARTONGUM, CHEWING1506
68196-309-47members mark nicotine1 in 1 BLISTER PACKGUM, CHEWING16
68196-309-87members mark nicotine2 in 1 PACKAGEGUM, CHEWING26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-309MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC]5Current NDC, Legacy NDC, 9 package rows20241215_0ea1d300-d77a-4262-b74c-583455606a2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN0ea1d300-d77a-4262-b74c-583455606a2c6
311975nicotine 4 MG Chewing GumSCD0ea1d300-d77a-4262-b74c-583455606a2c6
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY0ea1d300-d77a-4262-b74c-583455606a2c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-309-2568196030925110 in 1 CARTONHistorical
68196-309-2968196030929110 in 1 CARTONHistorical
68196-309-3068196030930300 BLISTER PACK in 1 CARTON (68196-309-30) / 1 GUM, CHEWING in 1 BLISTER PACK300 blister pack2025-09-11NoNoCurrent
68196-309-4768196030947150 BLISTER PACK in 1 CARTON (68196-309-47) > 1 GUM, CHEWING in 1 BLISTER PACK150 blister pack2019-04-180000-00-00NoNoCurrent
68196-309-87681960309872 CARTON in 1 PACKAGE (68196-309-87) / 150 BLISTER PACK in 1 CARTON (68196-309-47) / 1 GUM, CHEWING in 1 BLISTER PACK2 carton2019-04-180000-00-00NoNoCurrent