Nicotine

Product NDC
63868-848
11-digit product format
638680848
Labeler code
63868
Product ID
63868-848_ca1001ad-f698-4ba0-9b1b-63ef3cb1a9d9
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
ANDA074707
Marketing category
ANDA
Marketing start
2020-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-848-112023-05-08C16284748780-1f386c64a-1f14-0266-e053-dadaa90a7c1a11b23262-676e-44fb-a853-43c1a64d57eb
63868-848-112023-01-30C16284748780-1f386c64a-1f14-0266-e053-dadaa90a7c1a11b23262-676e-44fb-a853-43c1a64d57eb

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-848-11EA - Each63868-848c28c8612-bf76-44c5-9133-6270f91e1f0312022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-848NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Legacy NDC20230509_11b23262-676e-44fb-a853-43c1a64d57eb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-848-1163868084811110 BLISTER PACK in 1 CARTON (63868-848-11) > 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2020-12-310000-00-00NoNoCurrent