NDC 36800-344

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 ID36800-344_2491860b-a095-4eb9-abc1-ec4619c2c5e3
NDC36800-344
Product TypeHuman Otc Drug
Proprietary NameTopcare Nicotine Polacrilex
Generic NameNicotine Polacrilex
Dosage FormLozenge
Route of AdministrationORAL
Marketing Start Date2009-09-03
Marketing CategoryANDA / ANDA
Application NumberANDA077007
Labeler NameTopco Associates LLC
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-344-05

3 CONTAINER in 1 CARTON (36800-344-05) > 24 LOZENGE in 1 CONTAINER (36800-344-03)
Marketing Start Date2009-09-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-344-05 [36800034405]

Topcare Nicotine Polacrilex LOZENGE
Marketing CategoryANDA
Application NumberANDA077007
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2009-09-03

NDC 36800-344-06 [36800034406]

Topcare Nicotine Polacrilex LOZENGE
Marketing CategoryANDA
Application NumberANDA077007
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-09-15

NDC 36800-344-03 [36800034403]

Topcare Nicotine Polacrilex LOZENGE
Marketing CategoryANDA
Application NumberANDA077007
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2012-01-31

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

OpenFDA Data

SPL SET ID:01e90106-4f97-4ae4-8d48-3e5adffd716b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359817
  • UPC Code
  • 0012345678905
  • Medicade Reported Pricing

    36800034405 NICOTINE 2 MG LOZENGE

    Pricing Unit: EA | Drug Type:

    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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