Nicotine Polacrilex

Product NDC
56062-428
11-digit product format
560620428
Labeler code
56062
Product ID
56062-428_beb2e867-a0cc-433c-82ed-3c191075049d
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
Publix Supermarkets, Inc.
Application
ANDA078699
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
2027-01-01
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 Polacrilex
Brand name suffix
Coated Mint

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975, 314119

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-428-44Nicotine PolacrilexCoated Mint10 in 1 CARTONGUM, CHEWING1014
56062-428-44Nicotine PolacrilexCoated Mint10 in 1 BLISTER PACKGUM, CHEWING1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-428NICOTINE POLACRILEX COATED MINT (NICOTINE POLACRILEX) GUM, CHEWING [PUBLIX SUPERMARKETS, INC.]12Current NDC, Legacy NDC, 2 package rows20240731_a6ef9fd0-9706-4924-b7f5-e2562b9d99e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNa6ef9fd0-9706-4924-b7f5-e2562b9d99e014
311975nicotine polacrilex 4 MG Chewing GumPSNa6ef9fd0-9706-4924-b7f5-e2562b9d99e014
314119nicotine 2 MG Chewing GumSCDa6ef9fd0-9706-4924-b7f5-e2562b9d99e014
311975nicotine 4 MG Chewing GumSCDa6ef9fd0-9706-4924-b7f5-e2562b9d99e014
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYa6ef9fd0-9706-4924-b7f5-e2562b9d99e014
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYa6ef9fd0-9706-4924-b7f5-e2562b9d99e014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-428-445606204284410 BLISTER PACK in 1 CARTON (56062-428-44) / 10 GUM, CHEWING in 1 BLISTER PACK10 blister pack2014-01-012027-01-01NoNoCurrent