NDC 0536-3113

Rugby Nicotine Polacrilex Gum, Coated Mint Flavor

Nicotine Polacrilex

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

Product ID0536-3113_226455b9-f0cc-4777-afc3-d0196ed860f9
NDC0536-3113
Product TypeHuman Otc Drug
Proprietary NameRugby Nicotine Polacrilex Gum, Coated Mint Flavor
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationBUCCAL
Marketing Start Date2008-12-29
Marketing CategoryANDA / ANDA
Application NumberANDA078697
Labeler NameRugby Laboratories, Inc.
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
Pharm ClassesCholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0536-3113-01

10 BLISTER PACK in 1 CARTON (0536-3113-01) > 10 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2008-12-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-3113-37 [00536311337]

Rugby Nicotine Polacrilex Gum, Coated Mint Flavor GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA078697
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2008-12-29

NDC 0536-3113-01 [00536311301]

Rugby Nicotine Polacrilex Gum, Coated Mint Flavor GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA078697
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2008-12-29

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:621eb214-0716-4306-829f-6185a77f24d5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • 314119

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

    NDCBrand NameGeneric Name
    0536-3112Rugby Nicotine Polacrilex Gum, Coated Mint FlavorRugby Nicotine Polacrilex Gum, Coated Mint Flavor
    0536-3113Rugby Nicotine Polacrilex Gum, Coated Mint FlavorRugby Nicotine Polacrilex Gum, Coated Mint 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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