NDC 36800-456

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 ID36800-456_10ad8344-6cc3-4539-915e-1919b3b65dcc
NDC36800-456
Product TypeHuman Otc Drug
Proprietary NameTopcare Nicotine
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2006-12-18
Marketing CategoryANDA / ANDA
Application NumberANDA076777
Labeler NameTopco Associates LLC
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 36800-456-60

20 BLISTER PACK in 1 CARTON (36800-456-60) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2013-02-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-456-78 [36800045678]

Topcare Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076777
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2006-12-18

NDC 36800-456-76 [36800045676]

Topcare Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076777
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-08-19

NDC 36800-456-60 [36800045660]

Topcare Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076777
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-02-06

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

OpenFDA Data

SPL SET ID:440178c0-e9e4-4729-bcd9-f640742c4080
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314119
  • UPC Code
  • 0012345678905
  • Medicade Reported Pricing

    36800045678 NICOTINE 2 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

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