Nicotine Polacrilex

Product NDC
0363-9270
11-digit product format
003639270
Labeler code
0363
Product ID
0363-9270_0e447180-c9e7-4464-b777-b63f320b5c1f
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreens
Application
ANDA078699
Marketing category
ANDA
Marketing start
2021-04-30
Marketing end
2027-09-28
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 Polacrilex

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
0363-9270-10Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING16
0363-9270-10Nicotine Polacrilex100 in 1 CARTONGUM, CHEWING1006
0363-9270-16Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING16
0363-9270-16Nicotine Polacrilex160 in 1 CARTONGUM, CHEWING1606
0363-9270-20Nicotine Polacrilex20 in 1 CARTONGUM, CHEWING206
0363-9270-20Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9270NICOTINE POLACRILEX GUM, CHEWING [WALGREENS]4Current NDC, Legacy NDC, 6 package rows20221008_fe5c4bfd-a792-4923-b2db-16be44d599ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNfe5c4bfd-a792-4923-b2db-16be44d599ea6
314119nicotine 2 MG Chewing GumSCDfe5c4bfd-a792-4923-b2db-16be44d599ea6
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYfe5c4bfd-a792-4923-b2db-16be44d599ea6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9270-1000363927010100 BLISTER PACK in 1 CARTON (0363-9270-10) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2021-04-302027-09-28NoNoCurrent
0363-9270-1600363927016160 BLISTER PACK in 1 CARTON (0363-9270-16) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2021-04-302027-09-28NoNoCurrent
0363-9270-200036392702020 BLISTER PACK in 1 CARTON (0363-9270-20) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2021-04-302027-09-28NoNoCurrent