NDC 0009-5400

Nicotrol

Nicotine

Nicotrol is a Respiratory (inhalation) Inhalant in the Human Prescription Drug category. It is labeled and distributed by Pharmacia & Upjohn Company Llc. The primary component is Nicotine.

Product ID0009-5400_00c25938-fb91-4e66-ac58-11b6e10d6d3a
NDC0009-5400
Product TypeHuman Prescription Drug
Proprietary NameNicotrol
Generic NameNicotine
Dosage FormInhalant
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date1997-05-02
Marketing CategoryNDA / NDA
Application NumberNDA020714
Labeler NamePharmacia & Upjohn Company LLC
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
Pharm ClassesCholinergic Nicotinic Agonist [EPC],Nicotine [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0009-5400-01

28 TRAY in 1 CARTON (0009-5400-01) > 6 CARTRIDGE in 1 TRAY > 1 INHALANT in 1 CARTRIDGE
Marketing Start Date1997-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0009-5400-01 [00009540001]

Nicotrol INHALANT
Marketing CategoryNDA
Application NumberNDA020714
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-05-02

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:62245d7d-b50d-48d9-9f03-071c61620ccf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046920
  • 250983

    • Pharmacological Class

    • Cholinergic Nicotinic Agonist [EPC]
    • Nicotine [CS]

    NDC Crossover Matching brand name "Nicotrol" or generic name "Nicotine"

    NDCBrand NameGeneric Name
    0009-5400Nicotrolnicotine
    0009-5401Nicotrolnicotine
    0067-6011Meijer NICOTINE TRANSDERMAL SYSTEMNICOTINE
    0067-6012Meijer NICOTINE TRANSDERMAL SYSTEMNICOTINE
    0067-6013Meijer NICOTINE TRANSDERMAL SYSTEMNICOTINE
    0135-0194NICODERMnicotine
    0135-0195NICODERMnicotine
    0135-0196NICODERMnicotine
    0363-0451NicotineNicotine
    0363-0455NicotineNicotine
    0363-0457NicotineNicotine
    0536-1106NICOTINENICOTINE
    0536-1107NICOTINENICOTINE
    0536-1108NICOTINENICOTINE
    0536-5894NicotineNicotine
    0536-5895NicotineNicotine
    0536-5896NicotineNicotine
    11673-194NICOTINEnicotine
    0220-3657NicotinumNICOTINE

    Trademark Results [Nicotrol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NICOTROL
    NICOTROL
    74006504 1733922 Live/Registered
    WARNER-LAMBERT COMPANY
    1989-11-17
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