Nicotine

Product NDC
59726-929
11-digit product format
597260929
Labeler code
59726
Product ID
59726-929_2ca27fc7-029d-450e-881c-0dacf31f5cf4
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA074507
Marketing category
ANDA
Marketing start
2024-03-01
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6M3C89ZY6RNICOTINE54-11-5NICOTINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59726-929-1759726092917170 BLISTER PACK in 1 CARTON (59726-929-17) / 1 GUM, CHEWING in 1 BLISTER PACK170 blister pack2024-03-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsP & L Development, LLC2026-02-27HUMAN OTC DRUG LABEL3