FDA.reportPublic FDA data

Rugby Nicotine Polacrilex Gum, Coated Mint Flavor

Product NDC
0536-3113
11-digit product format
005363113
Labeler code
0536
Product ID
0536-3113_665390ec-cda3-4603-883c-5593a4b40dd8
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
Rugby Laboratories
Application
ANDA078697
Marketing category
ANDA
Marketing start
2008-12-29
Substance
NICOTINE
Active strength
4 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, Coated Mint Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 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
0536-3113-01Rugby Nicotine Polacrilex Gum, Coated Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1016
0536-3113-01Rugby Nicotine Polacrilex Gum, Coated Mint Flavor10 in 1 CARTONGUM, CHEWING1016
0536-3113-37Rugby Nicotine Polacrilex Gum, Coated Mint Flavor4 in 1 CARTONGUM, CHEWING416
0536-3113-37Rugby Nicotine Polacrilex Gum, Coated Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3113-01EA - Each0536-3113615c36dc-59ac-4e9b-bbfb-fa933571b40a12013-02-13
0536-3113-37EA - Each0536-311323fc779e-1d25-4774-9159-80fb1e4f029312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
NICOTINEACTIVE MOIETY6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
ACACIAINACTIVE INGREDIENT5C5403N26ORUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9RUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933RUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QORUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
TALCINACTIVE INGREDIENT7SEV7J4R1URUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ERUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-3113RUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES, INC.]14Current NDC, Legacy NDC, 4 package rows20241127_621eb214-0716-4306-829f-6185a77f24d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN621eb214-0716-4306-829f-6185a77f24d516
311975nicotine polacrilex 4 MG Chewing GumPSN621eb214-0716-4306-829f-6185a77f24d516
314119nicotine 2 MG Chewing GumSCD621eb214-0716-4306-829f-6185a77f24d516
311975nicotine 4 MG Chewing GumSCD621eb214-0716-4306-829f-6185a77f24d516
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY621eb214-0716-4306-829f-6185a77f24d516
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY621eb214-0716-4306-829f-6185a77f24d516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-3113-010053631130110 BLISTER PACK in 1 CARTON (0536-3113-01) / 10 GUM, CHEWING in 1 BLISTER PACK10 blister pack2008-12-290000-00-00NoNoCurrent
0536-3113-37005363113374 BLISTER PACK in 1 CARTON (0536-3113-37) / 10 GUM, CHEWING in 1 BLISTER PACK4 blister pack2008-12-290000-00-00NoNoCurrent