nicotine

Product NDC
79481-0103
11-digit product format
794810103
Labeler code
79481
Product ID
79481-0103_d538d813-42d7-4016-92df-f580714e957b
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA206393
Marketing category
ANDA
Marketing start
2023-06-23
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
79481-0103-079481010300100 BLISTER PACK in 1 CAPSULE (79481-0103-0) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2023-06-23NoNoHistorical
79481-0103-179481010301120 BLISTER PACK in 1 CARTON (79481-0103-1) / 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2023-06-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Meijer Distribution, Inc. Nicotine Gum Drug FactsMeijer, Inc.2023-06-29HUMAN OTC DRUG LABEL2