NDC 36800-532

Topcare Nicotine

Nicotine Polacrilex

Topcare Nicotine is a Oral Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Nicotine.

Product ID36800-532_28e82010-9a93-4cde-a733-aec52011ecd2
NDC36800-532
Product TypeHuman Otc Drug
Proprietary NameTopcare Nicotine
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2006-10-30
Marketing CategoryANDA / ANDA
Application NumberANDA076779
Labeler NameTopco Associates LLC
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 36800-532-60

20 BLISTER PACK in 1 CARTON (36800-532-60) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2013-01-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-532-60 [36800053260]

Topcare Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076779
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2013-01-23

NDC 36800-532-76 [36800053276]

Topcare Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076779
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-08-25

NDC 36800-532-78 [36800053278]

Topcare Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076779
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2006-10-30

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:fa916f6b-0582-4e2a-bbed-6c47778c5d03
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • Medicade Reported Pricing

    36800053278 NICOTINE 4 MG CHEWING GUM

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Topcare Nicotine" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    36800-170Topcare NicotineTopcare Nicotine
    36800-456Topcare NicotineTopcare Nicotine
    36800-352Topcare nicotineTopcare nicotine
    36800-539Topcare NicotineTopcare Nicotine
    36800-532Topcare NicotineTopcare Nicotine
    36800-029TopCare NicotineTopCare Nicotine
    36800-206Topcare NicotineTopcare Nicotine
    36800-957Topcare NicotineTopcare Nicotine
    36800-873Topcare NicotineTopcare Nicotine
    36800-734Topcare NicotineTopcare Nicotine
    36800-650Topcare NicotineTopcare Nicotine
    36800-269topcare nicotinetopcare nicotine
    36800-967topcare nicotinetopcare 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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