FDA.reportPublic FDA data

berkley and jensen nicotine

Product NDC
68391-170
11-digit product format
683910170
Labeler code
68391
Product ID
68391-170_5af637bc-d55b-4928-9cd3-fb25c58b6ee1
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
BJWC
Application
ANDA076789
Marketing category
ANDA
Marketing start
2006-01-18
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
berkley and jensen 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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-170-06berkley and jensen nicotine160 in 1 CARTONGUM, CHEWING1607
68391-170-06berkley and jensen nicotine1 in 1 BLISTER PACKGUM, CHEWING17
68391-170-36berkley and jensen nicotine2 in 1 PACKAGEGUM, CHEWING27
68391-170-36berkley and jensen nicotine160 in 1 CARTONGUM, CHEWING1607
68391-170-76berkley and jensen nicotine1 in 1 BLISTER PACKGUM, CHEWING17
68391-170-76berkley and jensen nicotine120 in 1 CARTONGUM, CHEWING1207
68391-170-78berkley and jensen nicotine1 in 1 BLISTER PACKGUM, CHEWING17
68391-170-78berkley and jensen nicotine100 in 1 CARTONGUM, CHEWING1007
68391-170-82berkley and jensen nicotine100 in 1 CARTONGUM, CHEWING1007
68391-170-82berkley and jensen nicotine2 in 1 PACKAGEGUM, CHEWING27

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
NICOTINEACTIVE MOIETY6M3C89ZY6RBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
POLACRILININACTIVE INGREDIENTRCZ785HI7SBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
SORBITOLINACTIVE INGREDIENT506T60A25RBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-170BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]7Current NDC, Legacy NDC, 10 package rows20210406_cf91dba6-f461-4370-920b-bc148089afe7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNcf91dba6-f461-4370-920b-bc148089afe77
311975nicotine 4 MG Chewing GumSCDcf91dba6-f461-4370-920b-bc148089afe77
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYcf91dba6-f461-4370-920b-bc148089afe77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-170-0668391017006160 BLISTER PACK in 1 CARTON (68391-170-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2016-11-160000-00-00NoNoCurrent
68391-170-36683910170362 CARTON in 1 PACKAGE (68391-170-36) / 160 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK2 carton2016-11-160000-00-00NoNoCurrent
68391-170-76683910170761 in 1 BLISTER PACKHistorical
68391-170-78683910170781 in 1 BLISTER PACKHistorical
68391-170-8268391017082100 in 1 CARTONHistorical