FDA.reportPublic FDA data

members mark nicotine

Product NDC
68196-029
11-digit product format
681960029
Labeler code
68196
Product ID
68196-029_15245ea7-be50-4512-af1f-95bfd0bea453
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Sam's West Inc
Application
ANDA076775
Marketing category
ANDA
Marketing start
2005-09-30
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
Rxcui314119

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-029-01members mark nicotine2 in 1 PACKAGEGUM, CHEWING28
68196-029-06members mark nicotine160 in 1 CARTONGUM, CHEWING1608
68196-029-06members mark nicotine1 in 1 BLISTER PACKGUM, CHEWING18
68196-029-36members mark nicotine160 in 1 CARTONGUM, CHEWING1608
68196-029-36members mark nicotine2 in 1 PACKAGEGUM, CHEWING28
68196-029-38members mark nicotine1 in 1 BLISTER PACKGUM, CHEWING18
68196-029-38members mark nicotine380 in 1 CARTONGUM, CHEWING3808
68196-029-56members mark nicotine190 in 1 CARTONGUM, CHEWING1908
68196-029-56members mark nicotine1 in 1 BLISTER PACKGUM, CHEWING18
68196-029-70members mark nicotine2 in 1 PACKAGEGUM, CHEWING28
68196-029-70members mark nicotine120 in 1 CARTONGUM, CHEWING1208
68196-029-76members mark nicotine1 in 1 BLISTER PACKGUM, CHEWING18
68196-029-76members mark nicotine120 in 1 CARTONGUM, CHEWING1208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-029MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC]7Current NDC, Legacy NDC, 13 package rows20240713_2c43a498-a4fb-4ed1-b4ae-aecfd334945b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN2c43a498-a4fb-4ed1-b4ae-aecfd334945b8
314119nicotine 2 MG Chewing GumSCD2c43a498-a4fb-4ed1-b4ae-aecfd334945b8
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY2c43a498-a4fb-4ed1-b4ae-aecfd334945b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-029-01681960029012 CARTON in 1 PACKAGE (68196-029-01) / 190 BLISTER PACK in 1 CARTON (68196-029-56) / 1 GUM, CHEWING in 1 BLISTER PACK2 carton2019-06-220000-00-00NoNoCurrent
68196-029-0668196002906160 in 1 CARTONHistorical
68196-029-3668196002936160 in 1 CARTONHistorical
68196-029-3868196002938380 BLISTER PACK in 1 CARTON (68196-029-38) / 1 GUM, CHEWING in 1 BLISTER PACK380 blister pack2025-09-16NoNoCurrent
68196-029-5668196002956190 in 1 CARTONHistorical
68196-029-70681960029702 in 1 PACKAGEHistorical
68196-029-76681960029761 in 1 BLISTER PACKHistorical