NDC 0078-0545

Stalevo

Carbidopa, Levodopa, And Entacapone

Stalevo is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Carbidopa; Levodopa; Entacapone.

Product ID0078-0545_1cae6786-12ca-4130-b059-38ca82bc1880
NDC0078-0545
Product TypeHuman Prescription Drug
Proprietary NameStalevo
Generic NameCarbidopa, Levodopa, And Entacapone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-09-26
Marketing CategoryNDA / NDA
Application NumberNDA021485
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameCARBIDOPA; LEVODOPA; ENTACAPONE
Active Ingredient Strength31 mg/1; mg/1; mg/1
Pharm ClassesAromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0078-0545-05

100 TABLET, FILM COATED in 1 BOTTLE (0078-0545-05)
Marketing Start Date2008-09-26
Marketing End Date2021-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0545-05 [00078054505]

Stalevo TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021485
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-09-26

Drug Details

Active Ingredients

IngredientStrength
CARBIDOPA31.25 mg/1

OpenFDA Data

SPL SET ID:5edfc3e7-f80d-47ee-897a-c02ff4eb3e74
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 810087
  • 730988
  • 810083
  • 730992
  • 403850
  • 403851
  • 403852
  • 810090
  • 404551
  • 404552
  • 404553
  • 810094
    • UPC Code
  • 0300780409056
  • 0300780527057

    • Pharmacological Class

    • Aromatic Amino Acid [EPC]
    • Amino Acids
    • Aromatic [CS]
    • Catechol O-Methyltransferase Inhibitors [MoA]
    • Catechol-O-Methyltransferase Inhibitor [EPC]

    NDC Crossover Matching brand name "Stalevo" or generic name "Carbidopa, Levodopa, And Entacapone"

    NDCBrand NameGeneric Name
    0078-0407Stalevocarbidopa, levodopa, and entacapone
    0078-0408Stalevocarbidopa, levodopa, and entacapone
    0078-0409Stalevocarbidopa, levodopa, and entacapone
    0078-0527Stalevocarbidopa, levodopa, and entacapone
    0078-0544Stalevocarbidopa, levodopa, and entacapone
    0078-0545Stalevocarbidopa, levodopa, and entacapone
    52427-805Stalevocarbidopa, levodopa, and entacapone
    52427-809Stalevocarbidopa, levodopa, and entacapone
    52427-816Stalevocarbidopa, levodopa, and entacapone
    52427-827Stalevocarbidopa, levodopa, and entacapone
    52427-834Stalevocarbidopa, levodopa, and entacapone
    52427-842StalevoStalevo
    0781-5613Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and Entacapone
    0781-5625Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and Entacapone
    0781-5637Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and Entacapone
    0781-5641Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and Entacapone
    0781-5654Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and Entacapone
    0781-5669Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and Entacapone

    Trademark Results [Stalevo]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    STALEVO
    STALEVO
    76431957 2799827 Live/Registered
    Orion Corporation
    2002-07-16
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