NDC 68391-012

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 ID68391-012_12c76a0c-beac-408c-ba99-2add39736f5f
NDC68391-012
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 NumberANDA206394
Labeler NameBJWC
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68391-012-25

110 BLISTER PACK in 1 CARTON (68391-012-25) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2017-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68391-012-76 [68391001276]

Berkley and Jensen NICOTINE GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA206394
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-02-13

NDC 68391-012-29 [68391001229]

Berkley and Jensen NICOTINE GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA206394
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-28

NDC 68391-012-25 [68391001225]

Berkley and Jensen NICOTINE GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA206394
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-28

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

OpenFDA Data

SPL SET ID:cdaa2643-7630-41e8-bd48-4a760cf4a46a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314119
    • UPC Code
  • 0012345678905

    • 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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