NDC 36800-375

topcare nicotine polacrilex

Nicotine Polacrilex

topcare nicotine polacrilex is a Oral Lozenge in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Nicotine.

Product ID36800-375_9e612581-f787-4fd1-8642-1b5b55f6e178
NDC36800-375
Product TypeHuman Otc Drug
Proprietary Nametopcare nicotine polacrilex
Generic NameNicotine Polacrilex
Dosage FormLozenge
Route of AdministrationORAL
Marketing Start Date1998-06-22
Marketing CategoryANDA / ANDA
Application NumberANDA090711
Labeler NameTopco Associates LLC
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-375-05

3 CONTAINER in 1 CARTON (36800-375-05) > 24 LOZENGE in 1 CONTAINER
Marketing Start Date2013-02-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-375-05 [36800037505]

topcare nicotine polacrilex LOZENGE
Marketing CategoryANDA
Application NumberANDA090711
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-02-13

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

OpenFDA Data

SPL SET ID:d0403746-f866-42da-ad66-2a686c8bce01
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359817
  • UPC Code
  • 0012345678905
  • NDC Crossover Matching brand name "topcare nicotine polacrilex" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    36800-344Topcare Nicotine PolacrilexTopcare Nicotine Polacrilex
    36800-375topcare nicotine polacrilextopcare 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

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