NDC 68391-170

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 ID68391-170_5af637bc-d55b-4928-9cd3-fb25c58b6ee1
NDC68391-170
Product TypeHuman Otc Drug
Proprietary Nameberkley and jensen nicotine
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2006-01-18
Marketing CategoryANDA / ANDA
Application NumberANDA076789
Labeler NameBJWC
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68391-170-06

160 BLISTER PACK in 1 CARTON (68391-170-06) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2016-11-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68391-170-78 [68391017078]

berkley and jensen nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076789
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-10-20
Marketing End Date2018-05-01

NDC 68391-170-82 [68391017082]

berkley and jensen nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076789
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-01-18
Marketing End Date2006-01-18

NDC 68391-170-76 [68391017076]

berkley and jensen nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076789
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-12-06
Marketing End Date2012-09-01

NDC 68391-170-36 [68391017036]

berkley and jensen nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076789
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-11-16

NDC 68391-170-06 [68391017006]

berkley and jensen nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076789
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-11-16

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:cf91dba6-f461-4370-920b-bc148089afe7
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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