NICOTINE

Product NDC
59640-099
11-digit product format
596400099
Labeler code
59640
Product ID
59640-099_a1e9d410-d671-459a-83a2-b626bec5d71b
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
H E B
Application
ANDA077007
Marketing category
ANDA
Marketing start
2025-08-12
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
59640-099-27596400099272 CONTAINER in 1 CARTON (59640-099-27) / 40 LOZENGE in 1 CONTAINER (59640-099-58) 2 container2025-08-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HEB Nicotine Lozenges Drug FactsH E B2025-08-13HUMAN OTC DRUG LABEL2