NDC 0378-8303

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 Mylan Pharmaceuticals Inc.. The primary component is Carbidopa; Levodopa; Entacapone.

Product ID0378-8303_4c9f9e95-49dd-4da6-8dd1-5caba49cce1c
NDC0378-8303
Product TypeHuman Prescription Drug
Proprietary NameCarbidopa, Levodopa and Entacapone
Generic NameCarbidopa, Levodopa And Entacapone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-10-28
Marketing End Date2022-02-28
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021485
Labeler NameMylan Pharmaceuticals Inc.
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

Packaging

NDC 0378-8303-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8303-01)
Marketing Start Date2013-10-28
Marketing End Date2022-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8303-01 [00378830301]

Carbidopa, Levodopa and Entacapone TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021485
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-10-28

Drug Details

Active Ingredients

IngredientStrength
CARBIDOPA31.25 mg/1

OpenFDA Data

SPL SET ID:4a535af2-16fc-4fdf-92ec-7941ef23a63a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 730988
  • 810083
  • 403850
  • 403851
  • 403852
  • 810090

    • Pharmacological Class

    • Aromatic Amino Acid [EPC]
    • Amino Acids
    • Aromatic [CS]
    • Catechol O-Methyltransferase Inhibitors [MoA]
    • Catechol-O-Methyltransferase Inhibitor [EPC]
    • 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
    0378-8300Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    0378-8301Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    0378-8302Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    0378-8303Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    0378-8304Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    0378-8305Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    16571-689CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    16571-690CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    16571-691CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    16571-692CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    16571-693CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    16571-694CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    47335-001Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    47335-002Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    47335-003Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    47335-004Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    47335-005Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    47335-006Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    55648-782carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    55648-783carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    55648-784carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    55648-785carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    55648-786carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    55648-787carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    64679-782CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
    64679-783CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
    64679-784CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
    64679-785CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
    64679-786CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
    64679-787CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
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