Nicotine

Product NDC
11822-3337
11-digit product format
118223337
Labeler code
11822
Product ID
11822-3337_62d10c7e-ff44-4118-9034-fe36d6986c8f
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA079038
Marketing category
ANDA
Marketing start
2020-05-29
Marketing end
2026-05-29
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6M3C89ZY6RNICOTINE54-11-5NICOTINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-3337-211822333702100 BLISTER PACK in 1 CARTON (11822-3337-2) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2020-05-292026-05-29NoNoHistorical
11822-3337-31182233370320 BLISTER PACK in 1 CARTON (11822-3337-3) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2020-05-292026-05-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - EquateRite Aid Corporation2025-08-07HUMAN OTC DRUG LABEL8