FDA.reportPublic FDA data

Nicotine

Product NDC
0363-9250
11-digit product format
003639250
Labeler code
0363
Product ID
0363-9250_4c379eb0-3902-4c1a-a47e-464017fb482a
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
Walgreens
Application
ANDA079044
Marketing category
ANDA
Marketing start
2021-01-29
Marketing end
2027-05-01
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9250-10Nicotine100 in 1 CARTONGUM, CHEWING1005
0363-9250-10Nicotine1 in 1 BLISTER PACKGUM, CHEWING15
0363-9250-16Nicotine1 in 1 BLISTER PACKGUM, CHEWING15
0363-9250-16Nicotine160 in 1 CARTONGUM, CHEWING1605
0363-9250-20Nicotine20 in 1 CARTONGUM, CHEWING205
0363-9250-20Nicotine1 in 1 BLISTER PACKGUM, CHEWING15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9250NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREENS]4Current NDC, Legacy NDC, 6 package rows20221004_cce1153e-ad7b-4c8a-a4eb-5b08b4652688.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNcce1153e-ad7b-4c8a-a4eb-5b08b46526885
314119nicotine 2 MG Chewing GumSCDcce1153e-ad7b-4c8a-a4eb-5b08b46526885
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYcce1153e-ad7b-4c8a-a4eb-5b08b46526885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9250-1000363925010100 BLISTER PACK in 1 CARTON (0363-9250-10) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2021-01-292027-05-01NoNoCurrent
0363-9250-1600363925016160 BLISTER PACK in 1 CARTON (0363-9250-16) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2021-01-292027-05-01NoNoCurrent
0363-9250-200036392502020 BLISTER PACK in 1 CARTON (0363-9250-20) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2021-01-292027-05-01NoNoCurrent