NDC 36800-957

Topcare Nicotine

Nicotine Polacrilex

Topcare Nicotine 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 ID36800-957_bd043d8b-19d9-409b-9def-03befd19604d
NDC36800-957
Product TypeHuman Otc Drug
Proprietary NameTopcare Nicotine
Generic NameNicotine Polacrilex
Dosage FormLozenge
Route of AdministrationORAL
Marketing Start Date2013-02-14
Marketing CategoryANDA / ANDA
Application NumberANDA203690
Labeler NameTopco Associates LLC
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 36800-957-02

3 CONTAINER in 1 CARTON (36800-957-02) > 27 LOZENGE in 1 CONTAINER
Marketing Start Date2013-02-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-957-60 [36800095760]

Topcare Nicotine LOZENGE
Marketing CategoryANDA
Application NumberANDA203690
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-12-12

NDC 36800-957-02 [36800095702]

Topcare Nicotine LOZENGE
Marketing CategoryANDA
Application NumberANDA203690
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-02-14

NDC 36800-957-04 [36800095704]

Topcare Nicotine LOZENGE
Marketing CategoryANDA
Application NumberANDA203690
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-06-19

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:9f2f06c3-4d9b-4c1a-85e3-26f021be5d7c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359818
  • UPC Code
  • 0012345678905
  • Medicade Reported Pricing

    36800095702 NICOTINE 4 MG LOZENGE

    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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