Nicotine Polacrilex

Product NDC
71335-2729
11-digit product format
713352729
Labeler code
71335
Product ID
71335-2729_37bbec49-60dc-402d-bd98-77bb052767c6
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
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
71335-2729-1713352729013 CONTAINER in 1 CARTON (71335-2729-1) / 27 LOZENGE in 1 CONTAINER3 container2025-07-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nicotine Polacrilex Lozenge 2 mg Drug FactsBryant Ranch Prepack2025-07-29HUMAN OTC DRUG LABEL100