FDA.reportPublic FDA data

Rugby Nicotine Polacrilex Gum, Original Flavor

Product NDC
0536-3029
11-digit product format
005363029
Labeler code
0536
Product ID
0536-3029_a7fad73a-749d-4287-b756-2cd203b85d35
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
Rugby Laboratories
Application
ANDA074507
Marketing category
ANDA
Marketing start
1999-03-15
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
Rugby Nicotine Polacrilex Gum, Original Flavor
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-3029-06Rugby Nicotine Polacrilex Gum, Original Flavor5 in 1 CARTONGUM, CHEWING527
0536-3029-06Rugby Nicotine Polacrilex Gum, Original Flavor10 in 1 BLISTER PACKGUM, CHEWING1027
0536-3029-23Rugby Nicotine Polacrilex Gum, Original Flavor10 in 1 BLISTER PACKGUM, CHEWING1027
0536-3029-23Rugby Nicotine Polacrilex Gum, Original Flavor11 in 1 CARTONGUM, CHEWING1127
0536-3029-34Rugby Nicotine Polacrilex Gum, Original Flavor10 in 1 BLISTER PACKGUM, CHEWING1027
0536-3029-34Rugby Nicotine Polacrilex Gum, Original Flavor2 in 1 CARTONGUM, CHEWING227

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3029-06EA - Each0536-302979319670-6345-4500-bbe6-1a7d03fcfa9b12013-02-13
0536-3029-23EA - Each0536-30297bff0082-17f6-4473-81d4-a7be7cc0de7112013-02-13
0536-3029-34EA - Each0536-30290fc17380-3c30-449e-ad0d-ef03c3755ea312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
NICOTINEACTIVE MOIETY6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KRUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZRUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QORUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TRUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
SORBITOLINACTIVE INGREDIENT506T60A25RRUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7
TALCINACTIVE INGREDIENT7SEV7J4R1URUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-3029RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES, INC.]24Current NDC, Legacy NDC, 6 package rows20250201_1fc88637-4329-486e-82ab-19eeb06080a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN1fc88637-4329-486e-82ab-19eeb06080a627
311975nicotine polacrilex 4 MG Chewing GumPSN1fc88637-4329-486e-82ab-19eeb06080a627
314119nicotine 2 MG Chewing GumSCD1fc88637-4329-486e-82ab-19eeb06080a627
311975nicotine 4 MG Chewing GumSCD1fc88637-4329-486e-82ab-19eeb06080a627
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY1fc88637-4329-486e-82ab-19eeb06080a627
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY1fc88637-4329-486e-82ab-19eeb06080a627

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-3029-06005363029065 BLISTER PACK in 1 CARTON (0536-3029-06) / 10 GUM, CHEWING in 1 BLISTER PACK5 blister pack1999-03-150000-00-00NoNoCurrent
0536-3029-230053630292311 BLISTER PACK in 1 CARTON (0536-3029-23) / 10 GUM, CHEWING in 1 BLISTER PACK11 blister pack1999-03-150000-00-00NoNoCurrent
0536-3029-34005363029342 BLISTER PACK in 1 CARTON (0536-3029-34) / 10 GUM, CHEWING in 1 BLISTER PACK2 blister pack1999-03-150000-00-00NoNoCurrent