Nicotine

Product NDC
0363-3911
11-digit product format
003633911
Labeler code
0363
Product ID
0363-3911_c6eab86c-99d8-424c-b4a2-6be56cf6d603
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreens
Application
ANDA079219
Marketing category
ANDA
Marketing start
2020-10-30
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
0363-3911-1000363391110100 BLISTER PACK in 1 CARTON (0363-3911-10) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2020-10-30NoNoHistorical
0363-3911-1600363391116160 BLISTER PACK in 1 CARTON (0363-3911-16) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2020-10-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - EquateWalgreens2022-10-06HUMAN OTC DRUG LABEL5