Nicotine

Product NDC
63868-842
11-digit product format
638680842
Labeler code
63868
Product ID
63868-842_495451a3-9c2e-4d19-9cf8-337042f87498
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
ANDA079038
Marketing category
ANDA
Marketing start
2020-04-27
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
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
63868-842-20EA - Each63868-842cd995827-f4dc-41b6-b6d5-7ddef098432712022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-842NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4Legacy NDC20231018_16bbdc36-92e1-405d-8b14-b73d1ee53587.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-842-206386808422020 BLISTER PACK in 1 CARTON (63868-842-20) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2020-04-270000-00-00NoNoCurrent