FDA.reportPublic FDA data

Nicotine

Product NDC
0363-9310
11-digit product format
003639310
Labeler code
0363
Product ID
0363-9310_4a8db40d-2bbf-4fe5-9664-c83bc710504d
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreens
Application
ANDA079038
Marketing category
ANDA
Marketing start
2020-10-30
Marketing end
2027-08-28
Substance
NICOTINE
Active strength
4 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
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975

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
0363-9310-10Nicotine1 in 1 BLISTER PACKGUM, CHEWING16
0363-9310-10Nicotine100 in 1 CARTONGUM, CHEWING1006
0363-9310-16Nicotine160 in 1 CARTONGUM, CHEWING1606
0363-9310-16Nicotine1 in 1 BLISTER PACKGUM, CHEWING16
0363-9310-20Nicotine20 in 1 CARTONGUM, CHEWING206
0363-9310-20Nicotine1 in 1 BLISTER PACKGUM, CHEWING16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9310NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREENS]4Current NDC, Legacy NDC, 6 package rows20221004_dda17eef-cd75-4c82-b468-09111298282d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNdda17eef-cd75-4c82-b468-09111298282d6
311975nicotine 4 MG Chewing GumSCDdda17eef-cd75-4c82-b468-09111298282d6
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYdda17eef-cd75-4c82-b468-09111298282d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9310-1000363931010100 BLISTER PACK in 1 CARTON (0363-9310-10) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2020-10-302027-08-28NoNoCurrent
0363-9310-1600363931016160 BLISTER PACK in 1 CARTON (0363-9310-16) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2020-10-302027-08-28NoNoCurrent
0363-9310-200036393102020 BLISTER PACK in 1 CARTON (0363-9310-20) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2020-10-302027-08-28NoNoCurrent