NDC 68391-532

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 ID68391-532_0ea8745b-77c6-4dae-a64b-25187d7bbc05
NDC68391-532
Product TypeHuman Otc Drug
Proprietary Nameberkley and jensen nicotine
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2007-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA076779
Labeler NameBJWC
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68391-532-76

120 BLISTER PACK in 1 CARTON (68391-532-76) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2007-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68391-532-78 [68391053278]

berkley and jensen nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076779
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-05-31
Marketing End Date2019-04-01

NDC 68391-532-82 [68391053282]

berkley and jensen nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076779
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-05-31
Marketing End Date2019-04-01

NDC 68391-532-76 [68391053276]

berkley and jensen nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076779
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-05-31
Marketing End Date2012-01-01

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:87a62b3e-c403-4638-879d-c01abd8f1d5e
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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