NDC 69189-0492

CHANTIX

Varenicline Tartrate

CHANTIX is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Varenicline Tartrate.

Product ID69189-0492_e019fbcd-8038-4b99-91fe-e94adec0650d
NDC69189-0492
Product TypeHuman Prescription Drug
Proprietary NameCHANTIX
Generic NameVarenicline Tartrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-01-22
Marketing CategoryNDA / NDA
Application NumberNDA021928
Labeler NameAvera McKennan Hospital
Substance NameVARENICLINE TARTRATE
Active Ingredient Strength1 mg/1
Pharm ClassesPartial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 69189-0492-1

1 TABLET, FILM COATED in 1 DOSE PACK (69189-0492-1)
Marketing Start Date2016-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69189-0492-1 [69189049201]

CHANTIX TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021928
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-22
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
VARENICLINE TARTRATE.5 mg/1

OpenFDA Data

SPL SET ID:1053cbe5-dc3d-4d95-93de-0022a22a6ed1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 636671
  • 637188
  • Pharmacological Class

    • Partial Cholinergic Nicotinic Agonist [EPC]
    • Partial Cholinergic Nicotinic Agonists [MoA]

    NDC Crossover Matching brand name "CHANTIX" or generic name "Varenicline Tartrate"

    NDCBrand NameGeneric Name
    0069-0468CHANTIXvarenicline tartrate
    0069-0469CHANTIXvarenicline tartrate
    0069-0471CHANTIXvarenicline tartrate
    21695-633Chantixvarenicline tartrate
    21695-945CHANTIXvarenicline tartrate
    21695-946Chantixvarenicline tartrate
    43353-899CHANTIXvarenicline tartrate
    50090-0995CHANTIXvarenicline tartrate
    50090-0998CHANTIXvarenicline tartrate
    50090-3528CHANTIXvarenicline tartrate
    50090-4481CHANTIXvarenicline tartrate
    50090-4482CHANTIXvarenicline tartrate
    63187-618CHANTIXvarenicline tartrate
    63539-473CHANTIXvarenicline tartrate
    68151-4953CHANTIXCHANTIX
    68151-4952CHANTIXCHANTIX
    69189-0492CHANTIXCHANTIX
    71205-381CHANTIXCHANTIX
    49884-155Vareniclinevarenicline tartrate
    49884-156Vareniclinevarenicline tartrate
    49884-944Vareniclinevarenicline tartrate
    60687-648Vareniclinevarenicline tartrate

    Trademark Results [CHANTIX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CHANTIX
    CHANTIX
    88847451 not registered Live/Pending
    Pfizer Inc.
    2020-03-25
    CHANTIX
    CHANTIX
    88847449 not registered Live/Pending
    Pfizer Inc.
    2020-03-25
    CHANTIX
    CHANTIX
    78893080 3407173 Live/Registered
    Pfizer Inc.
    2006-05-25
    CHANTIX
    CHANTIX
    78875811 not registered Dead/Abandoned
    Pfizer Inc.
    2006-05-03
    CHANTIX
    CHANTIX
    78835879 3321317 Live/Registered
    Pfizer Inc.
    2006-03-13

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