NICOTINE

Product NDC
58602-906
11-digit product format
586020906
Labeler code
58602
Product ID
58602-906_cbf094d4-2357-426d-8205-9b59c332854f
Type
HUMAN OTC DRUG
Nonproprietary name
NICOTINE POLACRILEX
Dosage form
LOZENGE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA213266
Marketing category
ANDA
Marketing start
2021-10-29
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
58602-906-07586020906071 CONTAINER in 1 CARTON (58602-906-07) / 24 LOZENGE in 1 CONTAINER1 container2021-10-29NoNoHistorical
58602-906-51586020906513 CONTAINER in 1 CARTON (58602-906-51) / 24 LOZENGE in 1 CONTAINER3 container2021-10-29NoNoHistorical
58602-906-52586020906524 CONTAINER in 1 CARTON (58602-906-52) / 24 LOZENGE in 1 CONTAINER4 container2021-10-29NoNoHistorical
58602-906-65586020906656 CONTAINER in 1 CARTON (58602-906-65) / 24 LOZENGE in 1 CONTAINER6 container2021-10-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NICOTINE - Aurohealth LLC | APL HEALTHCARE LIMITEDAurohealth LLC | APL HEALTHCARE LIMITED2021-11-03Human OTC Drug Label1