NDC 0378-0088

Carbidopa and Levodopa

Carbidopa And Levodopa

Carbidopa and Levodopa is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Carbidopa; Levodopa.

Product ID0378-0088_040cbae3-06af-4478-b9fb-73562828fc3c
NDC0378-0088
Product TypeHuman Prescription Drug
Proprietary NameCarbidopa and Levodopa
Generic NameCarbidopa And Levodopa
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2000-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA075091
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCARBIDOPA; LEVODOPA
Active Ingredient Strength25 mg/1; mg/1
Pharm ClassesAmino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-0088-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0088-01)
Marketing Start Date2000-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0088-05 [00378008805]

Carbidopa and Levodopa TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075091
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-04-26
Marketing End Date2014-12-18

NDC 0378-0088-01 [00378008801]

Carbidopa and Levodopa TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075091
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-04-26

Drug Details

Active Ingredients

IngredientStrength
CARBIDOPA25 mg/1

OpenFDA Data

SPL SET ID:aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308988
  • 308989

    • Pharmacological Class

    • Aromatic Amino Acid [EPC]
    • Amino Acids
    • Aromatic [CS]

    NDC Crossover Matching brand name "Carbidopa and Levodopa" or generic name "Carbidopa And Levodopa"

    NDCBrand NameGeneric Name
    0093-9701Carbidopa and levodopaCarbidopa and levodopa
    0093-9702Carbidopa and levodopaCarbidopa and levodopa
    0228-2538Carbidopa and levodopaCarbidopa and levodopa
    0228-2539Carbidopa and levodopaCarbidopa and levodopa
    68001-172CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPA
    68001-171CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPA
    68071-4067CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPA
    68084-093Carbidopa and levodopaCarbidopa and levodopa
    68084-094Carbidopa and levodopaCarbidopa and levodopa
    68084-281Carbidopa and LevodopaCarbidopa and Levodopa
    68084-282Carbidopa and LevodopaCarbidopa and Levodopa
    68151-2887Carbidopa and LevodopaCarbidopa and Levodopa
    68788-9684CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPA
    0615-4504Carbidopa and levodopaCarbidopa and levodopa
    0615-3537Carbidopa and levodopaCarbidopa and levodopa
    0615-3561Carbidopa and levodopaCarbidopa and levodopa
    0615-4568Carbidopa and LevodopaCarbidopa and Levodopa
    0615-4569Carbidopa and LevodopaCarbidopa and Levodopa
    0615-8010Carbidopa and LevodopaCarbidopa and Levodopa
    0615-8067Carbidopa and levodopaCarbidopa and levodopa
    0615-8068Carbidopa and levodopaCarbidopa and levodopa
    0615-8011Carbidopa and LevodopaCarbidopa and Levodopa
    0615-8251Carbidopa and LevodopaCarbidopa and Levodopa
    0904-6238Carbidopa and LevodopaCarbidopa and Levodopa
    0904-6237Carbidopa and LevodopaCarbidopa and Levodopa
    16729-079CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPA
    16729-078CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPA
    43353-202Carbidopa and LevodopaCarbidopa and Levodopa
    43353-510Carbidopa and levodopaCarbidopa and levodopa
    43353-327Carbidopa and LevodopaCarbidopa and Levodopa
    47335-186CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPA
    47335-187CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPA
    47335-188CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPA
    50090-3419Carbidopa and levodopaCarbidopa and levodopa
    0228-2540Carbidopa and levodopaCarbidopa and levodopa
    51079-978Carbidopa and LevodopaCarbidopa and Levodopa
    51079-884Carbidopa and LevodopaCarbidopa and Levodopa
    51079-923Carbidopa and LevodopaCarbidopa and Levodopa
    51407-168Carbidopa and LevodopaCarbidopa and Levodopa
    51407-167Carbidopa and LevodopaCarbidopa and Levodopa
    51407-166Carbidopa and LevodopaCarbidopa and Levodopa
    51862-856Carbidopa and LevodopaCarbidopa and Levodopa
    51862-077CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPA
    51862-079Carbidopa and levodopaCarbidopa and levodopa
    51862-855Carbidopa and LevodopaCarbidopa and Levodopa
    51862-858Carbidopa and LevodopaCarbidopa and Levodopa
    51862-080Carbidopa and levodopaCarbidopa and levodopa
    55700-642Carbidopa and levodopaCarbidopa and levodopa
    60429-651Carbidopa and LevodopaCarbidopa and Levodopa
    60429-153Carbidopa and levodopaCarbidopa and levodopa
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.