NDC 0378-0421

Methyldopa

Methyldopa

Methyldopa is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Methyldopa.

Product ID0378-0421_5f985660-415a-40e4-a386-a513a1e7b80e
NDC0378-0421
Product TypeHuman Prescription Drug
Proprietary NameMethyldopa
Generic NameMethyldopa
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1985-04-18
Marketing CategoryANDA / ANDA
Application NumberANDA070076
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMETHYLDOPA
Active Ingredient Strength500 mg/1
Pharm ClassesAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-0421-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0421-01)
Marketing Start Date1985-04-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0421-01 [00378042101]

Methyldopa TABLET
Marketing CategoryANDA
Application NumberANDA070076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1985-04-18

NDC 0378-0421-05 [00378042105]

Methyldopa TABLET
Marketing CategoryANDA
Application NumberANDA070076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1985-04-18
Marketing End Date2013-07-08

Drug Details

Active Ingredients

IngredientStrength
METHYLDOPA500 mg/1

OpenFDA Data

SPL SET ID:bb1c7c3f-9e6f-4d0e-aea1-6974558659ef
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197956
  • 197958
  • Pharmacological Class

    • Adrenergic alpha2-Agonists [MoA]
    • Central alpha-2 Adrenergic Agonist [EPC]
    • Adrenergic alpha2-Agonists [MoA]
    • Central alpha-2 Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "Methyldopa" or generic name "Methyldopa"

    NDCBrand NameGeneric Name
    0378-0421Methyldopamethyldopa
    0378-0611Methyldopamethyldopa
    16729-030MethyldopaMethyldopa
    16729-031MethyldopaMethyldopa
    21695-879MethyldopaMethyldopa
    21695-880MethyldopaMethyldopa
    42254-351MethyldopaMethyldopa
    51079-200Methyldopamethyldopa
    51079-201Methyldopamethyldopa
    62135-321MethyldopaMethyldopa
    62135-322MethyldopaMethyldopa
    68151-2791MethyldopaMethyldopa

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.