NDC 0378-2097

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 ID0378-2097_18276df2-9ea6-4560-b8fc-18b0d8025342
NDC0378-2097
Product TypeHuman Prescription Drug
Proprietary NameNisoldipine
Generic NameNisoldipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-01-28
Marketing CategoryANDA / ANDA
Application NumberANDA091001
Labeler NameMylan Pharmaceuticals Inc.
Substance NameNISOLDIPINE
Active Ingredient Strength17 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-2097-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2097-01)
Marketing Start Date2011-01-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2097-01 [00378209701]

Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091001
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-28

NDC 0378-2097-05 [00378209705]

Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091001
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-28
Marketing End Date2015-02-02

Drug Details

Active Ingredients

IngredientStrength
NISOLDIPINE17 mg/1

OpenFDA Data

SPL SET ID:00d506a4-74d6-4838-b008-3f9e7c017e08
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 763574
  • 763519
  • 763589
  • 790489
  • 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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