FDA.reportPublic FDA data

Members Mark Nicotine

Product NDC
68196-971
11-digit product format
681960971
Labeler code
68196
Product ID
68196-971_00471a30-85ef-4bc2-90bf-3a130aec2507
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
2019-08-16
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Members Mark Nicotine
Listing expiration
2027-12-31

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
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-971-00Members Mark Nicotine300 in 1 CARTONGUM, CHEWING3005
68196-971-00Members Mark Nicotine1 in 1 BLISTER PACKGUM, CHEWING15
68196-971-47Members Mark Nicotine1 in 1 BLISTER PACKGUM, CHEWING15
68196-971-47Members Mark Nicotine150 in 1 CARTONGUM, CHEWING1505
68196-971-87Members Mark Nicotine150 in 1 CARTONGUM, CHEWING1505
68196-971-87Members Mark Nicotine2 in 1 CARTONGUM, CHEWING25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-971MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC]4Current NDC, Legacy NDC, 6 package rows20210421_69adad06-48f7-40d5-bca1-ae8e50ab1646.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN69adad06-48f7-40d5-bca1-ae8e50ab16465
311975nicotine 4 MG Chewing GumSCD69adad06-48f7-40d5-bca1-ae8e50ab16465
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY69adad06-48f7-40d5-bca1-ae8e50ab16465

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-971-0068196097100300 BLISTER PACK in 1 CARTON (68196-971-00) / 1 GUM, CHEWING in 1 BLISTER PACK300 blister pack2025-09-11NoNoCurrent
68196-971-4768196097147150 BLISTER PACK in 1 CARTON (68196-971-47) / 1 GUM, CHEWING in 1 BLISTER PACK150 blister pack2019-08-162026-12-31NoNoCurrent
68196-971-87681960971872 CARTON in 1 CARTON (68196-971-87) / 150 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK2 carton2019-08-162026-12-31NoNoCurrent