NDC 70515-501

Sular

Nisoldipine

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

Product ID70515-501_45a7200c-e81a-4b29-835b-f98e36c2a4f6
NDC70515-501
Product TypeHuman Prescription Drug
Proprietary NameSular
Generic NameNisoldipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-02-03
Marketing CategoryNDA / NDA
Application NumberNDA020356
Labeler NameCovis Pharma
Substance NameNISOLDIPINE
Active Ingredient Strength17 mg/1
Pharm ClassesDihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70515-501-10

1 BOTTLE in 1 CARTON (70515-501-10) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2017-02-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70515-501-10 [70515050110]

Sular TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-03

Drug Details

Active Ingredients

IngredientStrength
NISOLDIPINE17 mg/1

OpenFDA Data

SPL SET ID:589157fa-d129-4de3-be3d-e0e1c22c5873
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 790840
  • 790489
  • 763589
  • 763521
  • 763519
  • 763591
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    59630-500SULARNisoldipine
    59630-501SULARNisoldipine
    59630-503SULARNisoldipine
    70515-500Sularnisoldipine
    70515-501Sularnisoldipine
    70515-503Sularnisoldipine
    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

    Trademark Results [Sular]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SULAR
    SULAR
    75025753 2175325 Live/Registered
    COVIS PHARMA B.V.
    1995-11-30
    SULAR
    SULAR
    74322049 1939088 Live/Registered
    COVIS PHARMA B.V.
    1992-10-13

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