FDA.reportPublic FDA data

Rugby Nicotine Polacrilex Gum, Mint Flavor

Product NDC
50090-3560
11-digit product format
500903560
Labeler code
50090
Product ID
50090-3560_8daba42e-328d-4a3a-a233-0b457e7aa7f7
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
A-S Medication Solutions
Application
ANDA076569
Marketing category
ANDA
Marketing start
2004-07-29
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rugby Nicotine Polacrilex Gum, Mint Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3560-02023-02-07C16284748780-1f386c64a-3347-0266-e053-dadaa90a7c1aNicotine Polacrilex Gum 2 mg and 4 mg MINT - Rugby
50090-3560-02023-01-30C16284748780-1f386c64a-3347-0266-e053-dadaa90a7c1aNicotine Polacrilex Gum 2 mg and 4 mg MINT - Rugby

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3560-0Rugby Nicotine Polacrilex Gum, Mint Flavor11 in 1 CARTONGUM, CHEWING1116
50090-3560-0Rugby Nicotine Polacrilex Gum, Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3560-0EA - Each50090-3560829ebbcc-7edf-4460-b1c6-b5e3314ba7e312021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3560RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 2 package rows20240511_7b70162e-0087-466f-9b8b-8289b6e90e39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN7b70162e-0087-466f-9b8b-8289b6e90e3916
314119nicotine 2 MG Chewing GumSCD7b70162e-0087-466f-9b8b-8289b6e90e3916
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY7b70162e-0087-466f-9b8b-8289b6e90e3916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3560-05009035600011 BLISTER PACK in 1 CARTON (50090-3560-0) / 10 GUM, CHEWING in 1 BLISTER PACK11 blister pack2018-08-290000-00-00NoNoCurrent