FDA.reportPublic FDA data

berkley and jensen nicotine

Product NDC
68391-344
11-digit product format
683910344
Labeler code
68391
Product ID
68391-344_857cf1ac-8862-44a6-b145-a03cce37cf13
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
BJWC
Application
ANDA077007
Marketing category
ANDA
Marketing start
2006-05-02
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
Rxcui359817

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
68391-344-11berkley and jensen nicotine24 in 1 CONTAINERLOZENGE246
68391-344-11berkley and jensen nicotine7 in 1 CARTONLOZENGE76
68391-344-13berkley and jensen nicotine27 in 1 CONTAINERLOZENGE276
68391-344-13berkley and jensen nicotine7 in 1 CARTONLOZENGE76

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]3
NICOTINEACTIVE MOIETY6M3C89ZY6RBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ABERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]3
POLACRILININACTIVE INGREDIENTRCZ785HI7SBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]3
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]3
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]3
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-344BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]6Current NDC, Legacy NDC, 4 package rows20170804_3a408d89-974f-4a20-aee9-fb1fe0a7ef3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN3a408d89-974f-4a20-aee9-fb1fe0a7ef3e6
359817nicotine 2 MG Oral LozengeSCD3a408d89-974f-4a20-aee9-fb1fe0a7ef3e6
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY3a408d89-974f-4a20-aee9-fb1fe0a7ef3e6
359817nicotine 2 MG TrocheSY3a408d89-974f-4a20-aee9-fb1fe0a7ef3e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-344-116839103441124 in 1 CONTAINERHistorical
68391-344-13683910344137 CONTAINER in 1 CARTON (68391-344-13) / 27 LOZENGE in 1 CONTAINER7 container2016-08-260000-00-00NoNoCurrent