Nicotine

Product NDC
63868-843
11-digit product format
638680843
Labeler code
63868
Product ID
63868-843_84e0cb9b-429c-483d-8670-79ffba06a604
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
ANDA204833
Marketing category
ANDA
Marketing start
2021-01-29
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6M3C89ZY6RNICOTINE54-11-5NICOTINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-843-206386808432020 BLISTER PACK in 1 CARTON (63868-843-20) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2021-01-290000-00-00NoNoCurrent