Nicotine

Product NDC
63868-845
11-digit product format
638680845
Labeler code
63868
Product ID
63868-845_3b5f8669-a3b3-45bf-9132-4e0a8214eb51
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
ANDA204794
Marketing category
ANDA
Marketing start
2020-12-31
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-845-20EA - Each63868-8459489725c-77ce-4e3e-b0dc-22724d5d9ade12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-845NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4Legacy NDC20231018_69f41191-eb3a-4005-9bd0-72885fa94c54.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-845-206386808452020 BLISTER PACK in 1 CARTON (63868-845-20) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2020-12-310000-00-00NoNoCurrent