Nicotine Polacrilex

Product NDC
55910-933
11-digit product format
559100933
Labeler code
55910
Product ID
55910-933_8f863747-ff6c-484b-85ce-523d890471b0
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
ANDA204833
Marketing category
ANDA
Marketing start
2023-10-25
Marketing end
2027-04-30
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 Polacrilex

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
55910-933-10Nicotine Polacrilex10 in 1 CARTONGUM, CHEWING104
55910-933-10Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-933NICOTINE POLACRILEX GUM, CHEWING [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3Current NDC, 2 package rows20240823_ee883114-35ac-4b81-b8f1-4903d646dd84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNee883114-35ac-4b81-b8f1-4903d646dd844
311975nicotine 4 MG Chewing GumSCDee883114-35ac-4b81-b8f1-4903d646dd844
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYee883114-35ac-4b81-b8f1-4903d646dd844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-933-105591009331010 BLISTER PACK in 1 CARTON (55910-933-10) / 1 GUM, CHEWING in 1 BLISTER PACK10 blister pack2023-10-252027-04-30NoNoHistorical