Topcare Nicotine

Product NDC
76162-403
11-digit product format
761620403
Labeler code
76162
Product ID
76162-403_25aba504-b4ce-473d-862b-c878189a50a9
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA077007
Marketing category
ANDA
Marketing start
2023-06-30
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
76162-403-27761620403272 CONTAINER in 1 CARTON (76162-403-27) / 40 LOZENGE in 1 CONTAINER (76162-403-58) 2 container2023-06-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Topco Associates LLC. Nicotine Lozenge Drug FactsTopco Associates LLC2023-08-28HUMAN OTC DRUG LABEL2