Nicotine Polacrilex

Product NDC
63868-168
11-digit product format
638680168
Labeler code
63868
Product ID
63868-168_6d10f27b-9cd5-420a-bfc7-aad952b07f58
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
ANDA078699
Marketing category
ANDA
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-168-202023-05-08C16284748780-1f386c649-bcae-0266-e053-dadaa90a7c1aed71a525-c738-4df1-b5d7-9352e17f9166
63868-168-202023-01-30C16284748780-1f386c649-bcae-0266-e053-dadaa90a7c1aed71a525-c738-4df1-b5d7-9352e17f9166

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-168NICOTINE POLACRILEX GUM, CHEWING NICOTINE POLACRILEX (NICOITNE POLACRILEX) GUM, CHEWING [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]7Legacy NDC20230509_ed71a525-c738-4df1-b5d7-9352e17f9166.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-168-206386801682020 BLISTER PACK in 1 CARTON (63868-168-20) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2016-07-010000-00-00NoNoCurrent