Nicotine

Product NDC
0363-9350
11-digit product format
003639350
Labeler code
0363
Product ID
0363-9350_efd95e4e-6576-4061-9d99-26a920235ba1
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreens
Application
ANDA074707
Marketing category
ANDA
Marketing start
2019-12-27
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
0363-9350-30Nicotine300 in 1 CARTONGUM, CHEWING3005
0363-9350-30Nicotine1 in 1 BLISTER PACKGUM, CHEWING15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9350NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREENS]3Current NDC, Legacy NDC, 2 package rows20241019_d6c6c753-f604-473c-88b4-b5f83f1dd293.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNd6c6c753-f604-473c-88b4-b5f83f1dd2935
311975nicotine 4 MG Chewing GumSCDd6c6c753-f604-473c-88b4-b5f83f1dd2935
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYd6c6c753-f604-473c-88b4-b5f83f1dd2935

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9350-3000363935030300 BLISTER PACK in 1 CARTON (0363-9350-30) / 1 GUM, CHEWING in 1 BLISTER PACK300 blister pack2019-12-270000-00-00NoNoCurrent