NDC 0781-5613

Carbidopa, Levodopa, and Entacapone

Carbidopa, Levodopa, And Entacapone

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

Product ID0781-5613_1f90ca2f-e5b3-44a4-94a3-71b701abeb45
NDC0781-5613
Product TypeHuman Prescription Drug
Proprietary NameCarbidopa, Levodopa, and Entacapone
Generic NameCarbidopa, Levodopa, And Entacapone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-06-18
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021485
Labeler NameSandoz Inc
Substance NameCARBIDOPA; LEVODOPA; ENTACAPONE
Active Ingredient Strength13 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 0781-5613-01

100 TABLET, FILM COATED in 1 BOTTLE (0781-5613-01)
Marketing Start Date2014-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5613-01 [00781561301]

Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021485
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-18

Drug Details

Active Ingredients

IngredientStrength
CARBIDOPA12.5 mg/1

OpenFDA Data

SPL SET ID:9c16c0e0-3b97-486b-b7d5-579f5853e2c5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 730988
  • 810083
  • 403850
  • 403851
  • 403852
  • 810090
    • UPC Code
  • 0307815669010

    • 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 "Carbidopa, Levodopa, and Entacapone" or generic name "Carbidopa, Levodopa, And Entacapone"

    NDCBrand NameGeneric Name
    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
    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
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