FDA.reportPublic FDA data

berkley and jensen nicotine

Product NDC
68391-734
11-digit product format
683910734
Labeler code
68391
Product ID
68391-734_1055f032-3a6e-40d3-8343-d144953c143d
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
BJWC
Application
ANDA203690
Marketing category
ANDA
Marketing start
2017-11-06
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
68391-734-01berkley and jensen nicotine27 in 1 BOTTLELOZENGE271
68391-734-06berkley and jensen nicotine27 in 1 BOTTLELOZENGE271
68391-734-06berkley and jensen nicotine7 in 1 PACKAGELOZENGE71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-734BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]1Current NDC, Legacy NDC, 3 package rows20171122_1055f032-3a6e-40d3-8343-d144953c143d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN1055f032-3a6e-40d3-8343-d144953c143d1
359817nicotine 2 MG Oral LozengeSCD1055f032-3a6e-40d3-8343-d144953c143d1
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY1055f032-3a6e-40d3-8343-d144953c143d1
359817nicotine 2 MG TrocheSY1055f032-3a6e-40d3-8343-d144953c143d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-734-016839107340127 LOZENGE in 1 BOTTLE (68391-734-01) 27 lozenge2017-11-060000-00-00NoNoCurrent
68391-734-06683910734067 BOTTLE in 1 PACKAGE (68391-734-06) / 27 LOZENGE in 1 BOTTLE7 bottle2017-11-060000-00-00NoNoCurrent