nicotine

Product NDC
69842-587
11-digit product format
698420587
Labeler code
69842
Product ID
69842-587_c1c88c02-a362-4606-9118-3195bbb98eff
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA077007
Marketing category
ANDA
Marketing start
2024-05-03
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6M3C89ZY6RNICOTINE54-11-5NICOTINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69842-587-27698420587272 VIAL in 1 CARTON (69842-587-27) / 40 LOZENGE in 1 VIAL (69842-587-58) 2 vial2024-05-08NoNoHistorical
69842-587-60698420587601 VIAL in 1 CARTON (69842-587-60) / 20 LOZENGE in 1 VIAL1 vial2024-05-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CVS Pharmacy, Inc. Nicotine Lozenge Drug FactsCVS Pharmacy2024-05-08HUMAN OTC DRUG LABEL2