NDC 68196-016

Nicotine Coated Fruit Flavor

Nicotine Polacrilex

Nicotine Coated Fruit Flavor is a Oral Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Sam's West, Inc.. The primary component is Nicotine.

Product ID68196-016_90da0877-56b2-4a12-920a-ded47dc573a7
NDC68196-016
Product TypeHuman Otc Drug
Proprietary NameNicotine Coated Fruit Flavor
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2017-10-16
Marketing CategoryANDA / ANDA
Application NumberANDA079038
Labeler NameSam's West, Inc.
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68196-016-01

231 BLISTER PACK in 1 CARTON (68196-016-01) > 33 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2017-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68196-016-01 [68196001601]

Nicotine Coated Fruit Flavor GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA079038
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-16

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:b8429827-bc22-49df-90f3-318391caf586
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • 314119
  • NDC Crossover Matching brand name "Nicotine Coated Fruit Flavor" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    68196-016Nicotine Coated Fruit FlavorNicotine Coated Fruit Flavor
    68196-015Nicotine Coated Fruit FlavorNicotine 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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