NDC 0378-2222

Nisoldipine

Nisoldipine

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

Product ID0378-2222_c1d7747e-abdf-4cf7-b286-217fc9a86c80
NDC0378-2222
Product TypeHuman Prescription Drug
Proprietary NameNisoldipine
Generic NameNisoldipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-07-25
Marketing End Date2030-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA079051
Labeler NameMylan Pharmaceuticals Inc.
Substance NameNISOLDIPINE
Active Ingredient Strength20 mg/1
Pharm ClassesDihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE]
NDC Exclude FlagN

Packaging

NDC 0378-2222-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2222-01)
Marketing Start Date2008-07-25
Marketing End Date2030-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2222-01 [00378222201]

Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079051
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-07-25

Drug Details

Active Ingredients

IngredientStrength
NISOLDIPINE20 mg/1

OpenFDA Data

SPL SET ID:a6a8a8ba-3966-4f37-a58b-44d3b05bdc4e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311984
  • 311985
  • 360344
  • Pharmacological Class

    • Dihydropyridine Calcium Channel Blocker [EPC]
    • Dihydropyridines [CS]
    • Calcium Channel Antagonists [MoA]
    • Decreased Blood Pressure [PE]
    • Dihydropyridine Calcium Channel Blocker [EPC]
    • Dihydropyridines [CS]
    • Calcium Channel Antagonists [MoA]
    • Decreased Blood Pressure [PE]

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

    NDCBrand NameGeneric Name
    0378-2096Nisoldipinenisoldipine
    0378-2097Nisoldipinenisoldipine
    0378-2098Nisoldipinenisoldipine
    0378-2099Nisoldipinenisoldipine
    0378-2222NisoldipineNisoldipine
    0378-2223NisoldipineNisoldipine
    0378-2224NisoldipineNisoldipine
    0677-1978NisoldipineNisoldipine
    0677-1979NisoldipineNisoldipine
    0677-1980NisoldipineNisoldipine
    0677-1981NisoldipineNisoldipine
    66993-472NisoldipineNisoldipine
    66993-473NisoldipineNisoldipine
    66993-475NisoldipineNisoldipine
    59630-500SULARNisoldipine
    59630-501SULARNisoldipine
    59630-503SULARNisoldipine
    70515-500Sularnisoldipine
    70515-501Sularnisoldipine
    70515-503Sularnisoldipine

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