FDA.reportPublic FDA data

Berkley and Jensen NICOTINE

Product NDC
68391-012
11-digit product format
683910012
Labeler code
68391
Product ID
68391-012_929ade4f-1d64-49e8-8d1f-5704aa5150f6
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
BJWC
Application
ANDA206394
Marketing category
ANDA
Marketing start
2017-02-28
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-012-25Berkley and Jensen NICOTINE110 in 1 CARTONGUM, CHEWING1106
68391-012-25Berkley and Jensen NICOTINE1 in 1 BLISTER PACKGUM, CHEWING16
68391-012-29Berkley and Jensen NICOTINE2 in 1 CARTONGUM, CHEWING26
68391-012-29Berkley and Jensen NICOTINE110 in 1 CARTONGUM, CHEWING1106
68391-012-70Berkley and Jensen NICOTINE2 in 1 PACKAGEGUM, CHEWING26
68391-012-76Berkley and Jensen NICOTINE1 in 1 BLISTER PACKGUM, CHEWING16
68391-012-76Berkley and Jensen NICOTINE120 in 1 CARTONGUM, CHEWING1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-012BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]6Current NDC, Legacy NDC, 7 package rows20250410_cdaa2643-7630-41e8-bd48-4a760cf4a46a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNcdaa2643-7630-41e8-bd48-4a760cf4a46a6
314119nicotine 2 MG Chewing GumSCDcdaa2643-7630-41e8-bd48-4a760cf4a46a6
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYcdaa2643-7630-41e8-bd48-4a760cf4a46a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-012-2568391001225110 BLISTER PACK in 1 CARTON (68391-012-25) > 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2017-02-280000-00-00NoNoCurrent
68391-012-29683910012292 CARTON in 1 CARTON (68391-012-29) > 110 BLISTER PACK in 1 CARTON > 1 GUM, CHEWING in 1 BLISTER PACK2 carton2017-02-280000-00-00NoNoCurrent
68391-012-70683910012702 CARTON in 1 PACKAGE (68391-012-70) / 120 BLISTER PACK in 1 CARTON (68391-012-76) / 1 GUM, CHEWING in 1 BLISTER PACK2 carton2020-02-13NoNoCurrent
68391-012-7668391001276240 BLISTER PACK in 1 CARTON (68391-012-76) > 1 GUM, CHEWING in 1 BLISTER PACK240 blister pack2020-02-130000-00-00NoNoCurrent