NDC 64725-0691

Sunmark Nicotine

Nicotine Polacrilex

Sunmark Nicotine is a Oral Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Tya Pharmaceuticals. The primary component is Nicotine.

Product ID64725-0691_c8f056bb-0ec7-49bb-96c5-723dd5d93a41
NDC64725-0691
Product TypeHuman Otc Drug
Proprietary NameSunmark Nicotine
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2005-06-23
Marketing CategoryANDA / ANDA
Application NumberANDA078325
Labeler NameTYA Pharmaceuticals
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 64725-0691-1

100 GUM, CHEWING in 1 BOX (64725-0691-1)
Marketing Start Date2005-06-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64725-0691-1 [64725069101]

Sunmark Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA078325
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-06-23
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

OpenFDA Data

SPL SET ID:78e41a43-35ea-4c38-a8c3-0dcfc34c6a8e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314119
  • NDC Crossover Matching brand name "Sunmark Nicotine" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    49348-787Sunmark NicotineSunmark Nicotine
    49348-573sunmark nicotinesunmark nicotine
    49348-692Sunmark NicotineSunmark Nicotine
    49348-788Sunmark NicotineSunmark Nicotine
    49348-853Sunmark NicotineSunmark Nicotine
    49348-572Sunmark NicotineSunmark Nicotine
    49348-852Sunmark NicotineSunmark Nicotine
    49348-691Sunmark NicotineSunmark Nicotine
    50090-1155Sunmark NicotineSunmark Nicotine
    50090-1153Sunmark NicotineSunmark Nicotine
    64725-0691Sunmark NicotineSunmark Nicotine
    70677-0088sunmark nicotinesunmark nicotine
    70677-0089sunmark nicotinesunmark nicotine
    70677-0086sunmark nicotinesunmark nicotine
    70677-0085sunmark nicotinesunmark nicotine
    70677-0087sunmark nicotinesunmark nicotine
    70677-0090sunmark nicotinesunmark nicotine
    50090-4265Sunmark NicotineSunmark 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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