FDA.reportPublic FDA data

berkley and jensen nicotine

Product NDC
68391-957
11-digit product format
683910957
Labeler code
68391
Product ID
68391-957_357123fc-0972-4683-ab52-f95d46c1b6c9
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
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
Rxcui359818

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
68391-957-01berkley and jensen nicotine27 in 1 BOTTLELOZENGE271
68391-957-06berkley and jensen nicotine27 in 1 BOTTLELOZENGE271
68391-957-06berkley and jensen nicotine7 in 1 PACKAGELOZENGE71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-957BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]1Current NDC, Legacy NDC, 3 package rows20171117_357123fc-0972-4683-ab52-f95d46c1b6c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN357123fc-0972-4683-ab52-f95d46c1b6c91
359818nicotine 4 MG Oral LozengeSCD357123fc-0972-4683-ab52-f95d46c1b6c91
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY357123fc-0972-4683-ab52-f95d46c1b6c91
359818nicotine 4 MG TrocheSY357123fc-0972-4683-ab52-f95d46c1b6c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-957-016839109570127 LOZENGE in 1 BOTTLE (68391-957-01) 27 lozenge2017-11-060000-00-00NoNoCurrent
68391-957-06683910957067 BOTTLE in 1 PACKAGE (68391-957-06) / 27 LOZENGE in 1 BOTTLE7 bottle2017-11-060000-00-00NoNoCurrent