NDC 68196-013

Nicotine COATED ice mint

Nicotine Polacrilex

Nicotine COATED ice mint is a Oral Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Sam's West, Inc.. The primary component is Nicotine.

Product ID68196-013_1940594c-170d-45c0-99c8-69af018f0322
NDC68196-013
Product TypeHuman Otc Drug
Proprietary NameNicotine COATED ice mint
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2017-10-16
Marketing CategoryANDA / ANDA
Application NumberANDA204794
Labeler NameSam's West, Inc.
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68196-013-01

231 BLISTER PACK in 1 CARTON (68196-013-01) > 33 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2017-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68196-013-01 [68196001301]

Nicotine COATED ice mint GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA204794
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-16

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

OpenFDA Data

SPL SET ID:b11fde82-ea84-43b3-a0df-255d811259b7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • 314119
  • NDC Crossover Matching brand name "Nicotine COATED ice mint" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    68196-014Nicotine COATED ice mintNicotine COATED ice mint
    68196-013Nicotine COATED ice mintNicotine COATED ice mint
    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.