NDC 55316-422

Healthy Accents Nicotine

Nicotine Polacrilex

Healthy Accents Nicotine is a Oral Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Dza Brands Llc. The primary component is Nicotine.

Product ID55316-422_0c5fc4d1-f39d-409a-8abc-c46d4f3b7af8
NDC55316-422
Product TypeHuman Otc Drug
Proprietary NameHealthy Accents Nicotine
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2011-05-07
Marketing CategoryANDA / ANDA
Application NumberANDA078326
Labeler NameDZA Brands LLC
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55316-422-25

110 BLISTER PACK in 1 CARTON (55316-422-25) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2011-05-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-422-25 [55316042225]

Healthy Accents Nicotine GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA078326
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-05-07

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:bc814583-a932-468e-98a4-80957f0a90eb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • NDC Crossover Matching brand name "Healthy Accents Nicotine" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    55316-344Healthy Accents NicotineHealthy Accents Nicotine
    55316-422Healthy Accents NicotineHealthy Accents Nicotine
    55316-029healthy accents nicotinehealthy accents 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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