nicotine

Product NDC
79481-1123
11-digit product format
794811123
Labeler code
79481
Product ID
79481-1123_8946235f-be6c-4745-a038-eb3dd0f4a5df
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA077007
Marketing category
ANDA
Marketing start
2023-06-15
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
79481-1123-0794811123001 CONTAINER in 1 CARTON (79481-1123-0) / 20 LOZENGE in 1 CONTAINER1 container2023-06-15NoNoHistorical
79481-1123-1794811123012 CONTAINER in 1 CARTON (79481-1123-1) / 40 LOZENGE in 1 CONTAINER (79481-1123-2) 2 container2023-08-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Meijer Distribution, Inc. Nicotine Lozenge Drug FactsMeijer, Inc.2025-04-03HUMAN OTC DRUG LABEL3