Nicotine

Product NDC
63868-844
11-digit product format
638680844
Labeler code
63868
Product ID
63868-844_544fda93-7d93-4c71-af05-001928b11868
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
ANDA079044
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-844-202023-05-04C16284748780-1f386c649-d8a2-0266-e053-dadaa90a7c1aa512b8f6-4489-44b5-8d82-438785c6240e
63868-844-202023-01-30C16284748780-1f386c649-d8a2-0266-e053-dadaa90a7c1aa512b8f6-4489-44b5-8d82-438785c6240e

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-844-20EA - Each63868-844e7fd5e43-3fec-4017-99ab-4aeee4113b9512022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-844NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5Legacy NDC20230506_a512b8f6-4489-44b5-8d82-438785c6240e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-844-206386808442020 BLISTER PACK in 1 CARTON (63868-844-20) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2020-12-310000-00-00NoNoCurrent