FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
0536-3404
11-digit product format
005363404
Labeler code
0536
Product ID
0536-3404_05d9e501-7456-414d-ae98-ffe06a88d576
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
Rugby Laboratories
Application
ANDA079216
Marketing category
ANDA
Marketing start
2009-07-08
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Polacrilex
Listing expiration
2027-12-31

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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-3404-01Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING118
0536-3404-01Nicotine Polacrilex100 in 1 CARTONGUM, CHEWING10018
0536-3404-37Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING118
0536-3404-37Nicotine Polacrilex40 in 1 CARTONGUM, CHEWING4018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3404-01EA - Each0536-34042de30b31-015c-4764-ae73-58d6220ff0e812013-02-13
0536-3404-37EA - Each0536-3404c40527de-d7d2-430b-8ca9-62ad56fe1b2012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
NICOTINEACTIVE MOIETY6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
ACACIAINACTIVE INGREDIENT5C5403N26ORUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9RUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KRUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZRUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PRUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QORUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TRUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4RUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
TALCINACTIVE INGREDIENT7SEV7J4R1URUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ERUGBY NICOTINE POLACRILEX GUM, COATED CINNAMON FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-3404NICOTINE POLACRILEX GUM, CHEWING [RUGBY LABORATORIES, INC.]14Current NDC, Legacy NDC, 4 package rows20241127_d67149d5-4766-4b84-8205-f1a6b692f4c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNd67149d5-4766-4b84-8205-f1a6b692f4c918
311975nicotine polacrilex 4 MG Chewing GumPSNd67149d5-4766-4b84-8205-f1a6b692f4c918
314119nicotine 2 MG Chewing GumSCDd67149d5-4766-4b84-8205-f1a6b692f4c918
311975nicotine 4 MG Chewing GumSCDd67149d5-4766-4b84-8205-f1a6b692f4c918
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYd67149d5-4766-4b84-8205-f1a6b692f4c918
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYd67149d5-4766-4b84-8205-f1a6b692f4c918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-3404-0100536340401100 BLISTER PACK in 1 CARTON (0536-3404-01) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2009-07-080000-00-00NoNoCurrent
0536-3404-37005363404371 in 1 BLISTER PACKHistorical