NDC 0677-1981

Nisoldipine

Nisoldipine

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

Product ID0677-1981_64a32a66-e695-4fa9-b0e3-df33d91ffc4f
NDC0677-1981
Product TypeHuman Prescription Drug
Proprietary NameNisoldipine
Generic NameNisoldipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-09-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020356
Labeler NameUnited Research Laboratories, Inc.
Substance NameNISOLDIPINE
Active Ingredient Strength34 mg/1
Pharm ClassesDihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0677-1981-01

1 BOTTLE in 1 CARTON (0677-1981-01) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2009-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0677-1981-01 [00677198101]

Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA020356
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
NISOLDIPINE34 mg/1

OpenFDA Data

SPL SET ID:2abc5435-b2ca-4e08-89bc-ab7526781819
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 763574
  • 790489
  • 763589
  • 763519
  • Pharmacological Class

    • 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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