Nicotine Polacrilex

Product NDC
72162-2288
11-digit product format
721622288
Labeler code
72162
Product ID
72162-2288_e5b26006-f4f8-499e-acd3-e06e74e393fa
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203690
Marketing category
ANDA
Marketing start
2016-07-08
Substance
NICOTINE
Active strength
4 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
72162-2288-2721622288023 CONTAINER in 1 CARTON (72162-2288-2) / 27 LOZENGE in 1 CONTAINER3 container2024-04-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Perrigo Nicotine Polacrilex Lozenge Drug FactsBryant Ranch Prepack2025-04-03HUMAN OTC DRUG LABEL2