FDA.reportPublic FDA data

berkley and jensen nicotine polacrilex

Product NDC
68391-873
11-digit product format
683910873
Labeler code
68391
Product ID
68391-873_1b1ebcd0-e7ac-4c86-a922-fd02744b427e
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
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 polacrilex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359818

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
68391-873-11berkley and jensen nicotine polacrilex7 in 1 CARTONLOZENGE76
68391-873-11berkley and jensen nicotine polacrilex24 in 1 CONTAINERLOZENGE246
68391-873-13berkley and jensen nicotine polacrilex27 in 1 CONTAINERLOZENGE276
68391-873-13berkley and jensen nicotine polacrilex7 in 1 CARTONLOZENGE76

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-873BERKLEY AND JENSEN NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [BJWC]5Current NDC, Legacy NDC, 4 package rows20170627_b586ce1c-77cd-497c-b22c-8c97f54583ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNb586ce1c-77cd-497c-b22c-8c97f54583ba6
359818nicotine 4 MG Oral LozengeSCDb586ce1c-77cd-497c-b22c-8c97f54583ba6
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYb586ce1c-77cd-497c-b22c-8c97f54583ba6
359818nicotine 4 MG TrocheSYb586ce1c-77cd-497c-b22c-8c97f54583ba6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-873-11683910873117 in 1 CARTONHistorical
68391-873-13683910873137 CONTAINER in 1 CARTON (68391-873-13) / 27 LOZENGE in 1 CONTAINER7 container2016-11-230000-00-00NoNoCurrent