Nicotine Polacrilex

Product NDC
72162-2267
11-digit product format
721622267
Labeler code
72162
Product ID
72162-2267_c1090451-a2d4-4b30-b8be-47ec530516ae
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212796
Marketing category
ANDA
Marketing start
2020-06-09
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
72162-2267-2721622267023 BOTTLE in 1 CARTON (72162-2267-2) / 24 LOZENGE in 1 BOTTLE3 bottle2024-02-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsBryant Ranch Prepack2025-08-26HUMAN OTC DRUG LABEL103