nicotine

Product NDC
79481-0601
11-digit product format
794810601
Labeler code
79481
Product ID
79481-0601_38a8a6cd-21de-4e64-9c7d-534aa9362624
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA206393
Marketing category
ANDA
Marketing start
2023-08-03
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nicotine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0601-0nicotine220 in 1 CARTONGUM, CHEWING2204
79481-0601-0nicotine1 in 1 BLISTER PACKGUM, CHEWING14
79481-0601-1nicotine1 in 1 BLISTER PACKGUM, CHEWING14
79481-0601-1nicotine170 in 1 CARTONGUM, CHEWING1704

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0601NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER, INC.]3Current NDC, 4 package rows20250322_ce196036-d15a-4821-b49c-ea5340c00952.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNce196036-d15a-4821-b49c-ea5340c009524
311975nicotine 4 MG Chewing GumSCDce196036-d15a-4821-b49c-ea5340c009524
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYce196036-d15a-4821-b49c-ea5340c009524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0601-079481060100220 BLISTER PACK in 1 CARTON (79481-0601-0) / 1 GUM, CHEWING in 1 BLISTER PACK220 blister pack2023-08-03NoNoHistorical
79481-0601-179481060101170 BLISTER PACK in 1 CARTON (79481-0601-1) / 1 GUM, CHEWING in 1 BLISTER PACK170 blister pack2026-04-07NoNoHistorical