NDC 68016-286

Nicotine Polacrilex, Original

Nicotine Polacrilex

Nicotine Polacrilex, Original is a Buccal Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Chain Drug Consortium, Llc. The primary component is Nicotine.

Product ID68016-286_27b06d8d-e709-4305-b37f-d74487d29fd1
NDC68016-286
Product TypeHuman Otc Drug
Proprietary NameNicotine Polacrilex, Original
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationBUCCAL
Marketing Start Date2013-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA074507
Labeler NameChain Drug Consortium, LLC
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68016-286-62

11 BLISTER PACK in 1 CARTON (68016-286-62) > 10 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2013-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68016-286-62 [68016028662]

Nicotine Polacrilex, Original GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA074507
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2013-07-01

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

OpenFDA Data

SPL SET ID:cb67cd5e-9264-4530-a678-da299476f356
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • 314119
  • NDC Crossover Matching brand name "Nicotine Polacrilex, Original" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    68016-287Nicotine Polacrilex, OriginalNicotine Polacrilex, Original
    68016-286Nicotine Polacrilex, OriginalNicotine Polacrilex, Original
    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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