NDC 68391-309

Berkley and Jensen Nicotine

Nicotine Polacrilex

Berkley and Jensen Nicotine is a Oral Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Bjwc. The primary component is Nicotine.

Product ID68391-309_67471339-f7fb-48f9-9d02-55e0b7a59e8c
NDC68391-309
Product TypeHuman Otc Drug
Proprietary NameBerkley and Jensen Nicotine
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2017-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA206393
Labeler NameBJWC
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68391-309-25

110 BLISTER PACK in 1 CARTON (68391-309-25) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2017-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68391-309-29 [68391030929]

Berkley and Jensen Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA206393
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-28

NDC 68391-309-25 [68391030925]

Berkley and Jensen Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA206393
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-28

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:b04f4f1e-55d3-4486-acf1-6a93dc919f2d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975

    • NDC Crossover Matching brand name "Berkley and Jensen Nicotine" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    68391-532berkley and jensen nicotineberkley and jensen nicotine
    68391-029berkley and jensen nicotineberkley and jensen nicotine
    68391-309Berkley and Jensen NicotineBerkley and Jensen Nicotine
    68391-344berkley and jensen nicotineberkley and jensen nicotine
    68391-012Berkley and Jensen NICOTINEBerkley and Jensen NICOTINE
    68391-170berkley and jensen nicotineberkley and jensen nicotine
    68391-734berkley and jensen nicotineberkley and jensen nicotine
    68391-456berkley and jensen nicotineberkley and jensen nicotine
    68391-957berkley and jensen nicotineberkley and jensen nicotine
    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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