FDA.reportPublic FDA data

berkley and jensen nicotine

Product NDC
68391-029
11-digit product format
683910029
Labeler code
68391
Product ID
68391-029_8c2ce585-df30-4014-8b87-409ad8bf2621
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
BJWC
Application
ANDA076775
Marketing category
ANDA
Marketing start
2006-01-19
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
berkley and jensen 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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-029-06berkley and jensen nicotine160 in 1 CARTONGUM, CHEWING16011
68391-029-06berkley and jensen nicotine1 in 1 BLISTER PACKGUM, CHEWING111
68391-029-36berkley and jensen nicotine2 in 1 CARTONGUM, CHEWING211
68391-029-36berkley and jensen nicotine160 in 1 CARTONGUM, CHEWING16011
68391-029-76berkley and jensen nicotine1 in 1 BLISTER PACKGUM, CHEWING111
68391-029-76berkley and jensen nicotine120 in 1 CARTONGUM, CHEWING12011
68391-029-78berkley and jensen nicotine100 in 1 CARTONGUM, CHEWING10011
68391-029-78berkley and jensen nicotine1 in 1 BLISTER PACKGUM, CHEWING111
68391-029-82berkley and jensen nicotine100 in 1 CARTONGUM, CHEWING10011
68391-029-82berkley and jensen nicotine2 in 1 CARTONGUM, CHEWING211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]5
NICOTINEACTIVE MOIETY6M3C89ZY6RBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]5
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]5
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]5
POLACRILININACTIVE INGREDIENTRCZ785HI7SBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]5
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]5
SORBITOLINACTIVE INGREDIENT506T60A25RBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-029BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]11Current NDC, Legacy NDC, 10 package rows20250402_8fdfe95a-8bd9-4a77-a95d-0d373e279a4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN8fdfe95a-8bd9-4a77-a95d-0d373e279a4a11
314119nicotine 2 MG Chewing GumSCD8fdfe95a-8bd9-4a77-a95d-0d373e279a4a11
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY8fdfe95a-8bd9-4a77-a95d-0d373e279a4a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-029-0668391002906160 BLISTER PACK in 1 CARTON (68391-029-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2016-10-050000-00-00NoNoCurrent
68391-029-36683910029362 CARTON in 1 CARTON (68391-029-36) / 160 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK2 carton2016-10-050000-00-00NoNoCurrent
68391-029-76683910029761 in 1 BLISTER PACKHistorical
68391-029-7868391002978100 BLISTER PACK in 1 CARTON (68391-029-78) > 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2008-10-200000-00-00NoNoCurrent
68391-029-8268391002982100 in 1 CARTONHistorical