Good Sense Nicotine

Product NDC
0113-5023
11-digit product format
001135023
Labeler code
0113
Product ID
0113-5023_5c89061b-1452-4962-9f25-212f2ae8e41e
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA077007
Marketing category
ANDA
Marketing start
2024-04-18
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
0113-5023-27001135023272 CONTAINER in 1 CARTON (0113-5023-27) / 40 LOZENGE in 1 CONTAINER2 container2024-04-18NoNoHistorical
0113-5023-580011350235840 LOZENGE in 1 CONTAINER (0113-5023-58) 40 lozenge2024-04-18NoNoHistorical
0113-5023-60001135023601 CONTAINER in 1 CARTON (0113-5023-60) / 20 LOZENGE in 1 CONTAINER1 container2024-04-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Perrigo Nicotine Lozenge Drug FactsL. Perrigo Company2024-04-19HUMAN OTC DRUG LABEL1