Berkley and Jensen Nicotine

Product NDC
68391-023
11-digit product format
683910023
Labeler code
68391
Product ID
68391-023_07f395ea-0370-4519-868f-7a1d94cc3b88
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
BJWC
Application
ANDA203690
Marketing category
ANDA
Marketing start
2021-07-30
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
4 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-023BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) LOZENGE [BJWC]1Legacy NDC20210817_07f395ea-0370-4519-868f-7a1d94cc3b88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-023-16683910023167 CONTAINER in 1 CARTON (68391-023-16) > 27 LOZENGE in 1 CONTAINER7 container2021-07-300000-00-00NoNoCurrent