NDC 0536-3386

Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor

Nicotine Polacrilex

Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor is a Buccal Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Nicotine.

Product ID0536-3386_21fc6e8e-83a3-46f3-9591-f51f54de2c65
NDC0536-3386
Product TypeHuman Otc Drug
Proprietary NameRugby Nicotine Polacrilex Gum, Coated Fruit Flavor
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationBUCCAL
Marketing Start Date2009-07-08
Marketing CategoryANDA / ANDA
Application NumberANDA079044
Labeler NameRugby Laboratories
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0536-3386-01

10 BLISTER PACK in 1 CARTON (0536-3386-01) > 10 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2009-07-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-3386-01 [00536338601]

Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA079044
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2009-07-08

NDC 0536-3386-37 [00536338637]

Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA079044
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2009-07-08
Marketing End Date2016-06-30

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

OpenFDA Data

SPL SET ID:b973d045-7791-49c1-9216-4e0d51173735
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • 314119

    • NDC Crossover Matching brand name "Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    0536-3387Rugby Nicotine Polacrilex Gum, Coated Fruit FlavorRugby Nicotine Polacrilex Gum, Coated Fruit Flavor
    0536-3386Rugby Nicotine Polacrilex Gum, Coated Fruit FlavorRugby Nicotine Polacrilex Gum, Coated Fruit Flavor
    0113-0704basic care nicotineNicotine polacrilex
    0113-0713basic care nicotineNicotine Polacrilex
    0113-0749basic care nicotineNicotine Polacrilex
    0113-0761basic care nicotineNicotine Polacrilex
    0113-7007basic care nicotineNicotine Polacrilex
    0113-7008basic care nicotinenicotine polacrilex
    0113-7029basic care nicotineNicotine Polacrilex
    0113-0029Good Sense NicotineNicotine Polacrilex
    0113-0053Good Sense NicotineNicotine Polacrilex
    0113-0170Good Sense NicotineNicotine Polacrilex
    0113-0206good sense nicotineNicotine Polacrilex
    0113-0344Good Sense NicotineNicotine Polacrilex
    0113-0422Good Sense NicotineNicotine Polacrilex
    0113-0456Good Sense NicotineNicotine Polacrilex
    0113-0532Good Sense NicotineNicotine Polacrilex
    0113-0734Good Sense NicotineNicotine Polacrilex
    0113-0854Good Sense NicotineNicotine polacrilex
    0113-0873good sense nicotineNicotine Polacrilex
    0113-0957Good Sense NicotineNicotine Polacrilex
    0113-1125Good Sense NicotineNicotine Polacrilex
    0113-1190good sense nicotineNicotine Polacrilex
    0113-1352good sense nicotineNicotine Polacrilex
    0113-6000Tru Relief NicotineNicotine Polacrilex
    0113-6001Tru Relief NicotineNicotine Polacrilex
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