FDA.reportPublic FDA data

Berkley and Jensen Nicotine

Product NDC
68391-309
11-digit product format
683910309
Labeler code
68391
Product ID
68391-309_ecc73ee8-3d06-4daf-b93b-4d180cc6bc68
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
BJWC
Application
ANDA206393
Marketing category
ANDA
Marketing start
2017-02-28
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
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
68391-309-25Berkley and Jensen Nicotine1 in 1 BLISTER PACKGUM, CHEWING17
68391-309-25Berkley and Jensen Nicotine110 in 1 CARTONGUM, CHEWING1107
68391-309-29Berkley and Jensen Nicotine2 in 1 CARTONGUM, CHEWING27
68391-309-29Berkley and Jensen Nicotine110 in 1 CARTONGUM, CHEWING1107
68391-309-70Berkley and Jensen Nicotine120 in 1 CARTONGUM, CHEWING1207
68391-309-70Berkley and Jensen Nicotine2 in 1 CARTONGUM, CHEWING27
68391-309-76Berkley and Jensen Nicotine120 in 1 CARTONGUM, CHEWING1207
68391-309-76Berkley and Jensen Nicotine1 in 1 BLISTER PACKGUM, CHEWING17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-309BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]6Current NDC, Legacy NDC, 8 package rows20250315_b04f4f1e-55d3-4486-acf1-6a93dc919f2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNb04f4f1e-55d3-4486-acf1-6a93dc919f2d7
311975nicotine 4 MG Chewing GumSCDb04f4f1e-55d3-4486-acf1-6a93dc919f2d7
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYb04f4f1e-55d3-4486-acf1-6a93dc919f2d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-309-2568391030925110 BLISTER PACK in 1 CARTON (68391-309-25) > 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2017-02-280000-00-00NoNoCurrent
68391-309-29683910309292 CARTON in 1 CARTON (68391-309-29) > 110 BLISTER PACK in 1 CARTON > 1 GUM, CHEWING in 1 BLISTER PACK2 carton2017-02-280000-00-00NoNoCurrent
68391-309-70683910309702 CARTON in 1 CARTON (68391-309-70) / 120 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK2 carton2020-12-110000-00-00NoNoCurrent
68391-309-7668391030976120 BLISTER PACK in 1 CARTON (68391-309-76) > 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2020-12-110000-00-00NoNoCurrent