NDC 0135-0511

NICORETTE

Nicotine Polacrilex

NICORETTE is a Oral Lozenge in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Nicotine.

Product ID0135-0511_2885416b-416d-4c51-8a19-810d2c5679c6
NDC0135-0511
Product TypeHuman Otc Drug
Proprietary NameNICORETTE
Generic NameNicotine Polacrilex
Dosage FormLozenge
Route of AdministrationORAL
Marketing Start Date2010-10-19
Marketing CategoryNDA / NDA
Application NumberNDA021330
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0135-0511-01

3 CONTAINER in 1 CARTON (0135-0511-01) > 24 LOZENGE in 1 CONTAINER
Marketing Start Date2010-10-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0135-0511-02 [00135051102]

NICORETTE LOZENGE
Marketing CategoryNDA
Application NumberNDA021330
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Marketing End Date2014-12-31

NDC 0135-0511-01 [00135051101]

NICORETTE LOZENGE
Marketing CategoryNDA
Application NumberNDA021330
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Inactivation Date2020-01-31

NDC 0135-0511-07 [00135051107]

NICORETTE LOZENGE
Marketing CategoryNDA
Application NumberNDA021330
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-09-01
Inactivation Date2020-01-31

NDC 0135-0511-06 [00135051106]

NICORETTE LOZENGE
Marketing CategoryNDA
Application NumberNDA021330
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-09-01
Inactivation Date2020-01-31

NDC 0135-0511-03 [00135051103]

NICORETTE LOZENGE
Marketing CategoryNDA
Application NumberNDA021330
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-10-19
Marketing End Date2018-11-19

NDC 0135-0511-05 [00135051105]

NICORETTE LOZENGE
Marketing CategoryNDA
Application NumberNDA021330
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Marketing End Date2015-01-31

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:991704ed-781a-489b-8b56-0b558e8fc385
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 968851
  • 359818
  • 359817
  • 968849

    • NDC Crossover Matching brand name "NICORETTE" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    68151-5980NICORETTENICORETTE
    0135-0511NICORETTENICORETTE
    0135-0509NICORETTENICORETTE
    0135-0508NICORETTENICORETTE
    0135-0510NICORETTENICORETTE
    0135-0625NICORETTENICORETTE
    0135-0626NICORETTENICORETTE
    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

    Trademark Results [NICORETTE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NICORETTE
    NICORETTE
    97148669 not registered Live/Pending
    GlaxoSmithKline Consumer Healthcare, L.P.
    2021-11-30
    NICORETTE
    NICORETTE
    97148654 not registered Live/Pending
    GlaxoSmithKline Consumer Healthcare, L.P.
    2021-11-30
    NICORETTE
    NICORETTE
    97076449 not registered Live/Pending
    GlaxoSmithKline Consumer Healthcare, L.P.
    2021-10-15
    NICORETTE
    NICORETTE
    78026844 2670277 Dead/Cancelled
    GLAXOSMITHKLINE CONSUMER HEALTHCARE L.P.
    2000-09-20
    NICORETTE
    NICORETTE
    77006854 3509141 Live/Registered
    GlaxoSmithKline Consumer Healthcare L.P.
    2006-09-25
    NICORETTE
    NICORETTE
    75185006 2103431 Dead/Cancelled
    SmithKline Beecham Consumer Healthcare,L.P.
    1996-10-17
    NICORETTE
    NICORETTE
    75185005 2103430 Dead/Cancelled
    SmithKline Beecham Consumer Healthcare,L.P.
    1996-10-17
    NICORETTE
    NICORETTE
    73264072 1186363 Live/Registered
    AB Leo
    1980-05-29
    NICORETTE
    NICORETTE
    72464064 0992648 Live/Registered
    WARNER-LAMBERT COMPANY
    1973-07-27
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