NDC 36800-650

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 ID36800-650_95ae0fc8-9bfd-4caf-8836-ced4fbdf7fa4
NDC36800-650
Product TypeHuman Otc Drug
Proprietary NameTopcare Nicotine
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2017-02-13
Marketing CategoryANDA / ANDA
Application NumberANDA206393
Labeler NameTopco Associates LLC
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-650-60

20 BLISTER PACK in 1 CARTON (36800-650-60) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2017-02-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-650-60 [36800065060]

Topcare Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA206393
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-13

NDC 36800-650-78 [36800065078]

Topcare Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA206393
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-13

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:03d9708a-923c-4fd3-ac3d-6ab4a4d8a804
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.