NDC 68391-873

berkley and jensen nicotine polacrilex

Nicotine Polacrilex

berkley and jensen nicotine polacrilex is a Oral Lozenge in the Human Otc Drug category. It is labeled and distributed by Bjwc. The primary component is Nicotine.

Product ID68391-873_1bed10ac-1a5d-47cb-9133-d47dbae120ca
NDC68391-873
Product TypeHuman Otc Drug
Proprietary Nameberkley and jensen nicotine polacrilex
Generic NameNicotine Polacrilex
Dosage FormLozenge
Route of AdministrationORAL
Marketing Start Date2006-05-02
Marketing CategoryANDA / ANDA
Application NumberANDA077007
Labeler NameBJWC
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68391-873-13

7 CONTAINER in 1 CARTON (68391-873-13) > 27 LOZENGE in 1 CONTAINER
Marketing Start Date2016-11-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68391-873-13 [68391087313]

berkley and jensen nicotine polacrilex LOZENGE
Marketing CategoryANDA
Application NumberANDA077007
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-11-23

NDC 68391-873-11 [68391087311]

berkley and jensen nicotine polacrilex LOZENGE
Marketing CategoryANDA
Application NumberANDA077007
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-05-12
Marketing End Date2018-04-01

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:b586ce1c-77cd-497c-b22c-8c97f54583ba
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359818
    • UPC Code
  • 0012345678905

    • NDC Crossover Matching brand name "berkley and jensen nicotine polacrilex" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    68391-873berkley and jensen nicotine polacrilexberkley and jensen nicotine polacrilex
    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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.