NDC 68151-0089

Cardene SR

Nicardipine Hydrochloride

Cardene SR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Carilion Materials Management. The primary component is Nicardipine Hydrochloride.

Product ID68151-0089_f4b1511d-945c-41fa-8fcf-f30e931526b6
NDC68151-0089
Product TypeHuman Prescription Drug
Proprietary NameCardene SR
Generic NameNicardipine Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date1992-02-21
Marketing CategoryNDA / NDA
Application NumberNDA020005
Labeler NameCarilion Materials Management
Substance NameNICARDIPINE HYDROCHLORIDE
Active Ingredient Strength30 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC SPL Data Element Entries

NDC 68151-0089-0 [68151008900]

Cardene SR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-02-21
Marketing End Date2016-07-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NICARDIPINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:613c79eb-b34d-4fea-82d0-61b8c4840182
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 858587
  • 858589

    • Pharmacological Class

    • Calcium Channel Antagonists [MoA]
    • Dihydropyridine Calcium Channel Blocker [EPC]
    • Dihydropyridines [CS]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Cytochrome P450 2C8 Inhibitors [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]

    NDC Crossover Matching brand name "Cardene SR" or generic name "Nicardipine Hydrochloride"

    NDCBrand NameGeneric Name
    68151-0089Cardene SRCardene SR
    10122-313Cardene IVnicardipine hydrochloride
    10122-314Cardene IVnicardipine hydrochloride
    10122-325Cardene IVnicardipine hydrochloride
    43066-009CARDENE IVnicardipine hydrochloride
    43066-016CARDENE IVnicardipine hydrochloride
    43066-021Cardene IVnicardipine hydrochloride
    0143-9542Nicardipine HydrochlorideNicardipine Hydrochloride
    0143-9593Nicardipine HydrochlorideNicardipine Hydrochloride
    0143-9633Nicardipine HydrochlorideNicardipine Hydrochloride
    0143-9634Nicardipine HydrochlorideNicardipine Hydrochloride
    0143-9689Nicardipine HydrochlorideNicardipine Hydrochloride
    0378-1020Nicardipine Hydrochloridenicardipine hydrochloride
    0378-1430Nicardipine Hydrochloridenicardipine hydrochloride
    0517-0735Nicardipine Hydrochloridenicardipine hydrochloride
    0781-3204Nicardipine HydrochlorideNicardipine Hydrochloride
    0781-9324Nicardipine HydrochlorideNicardipine Hydrochloride
    14593-124Nicardipine HydrochlorideNicardipine Hydrochloride
    24658-750Nicardipine HydrochlorideNicardipine Hydrochloride
    24658-751Nicardipine HydrochlorideNicardipine Hydrochloride
    40042-047Nicardipine HydrochlorideNicardipine Hydrochloride
    42806-501Nicardipine HydrochlorideNicardipine Hydrochloride
    42806-502Nicardipine HydrochlorideNicardipine Hydrochloride

    Trademark Results [Cardene]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CARDENE
    CARDENE
    73492701 1352752 Dead/Cancelled
    DUPUY ENGINEERING S.A.
    1984-07-31
    CARDENE
    CARDENE
    73464988 1312013 Live/Registered
    Syntex (U.S.A) Inc.
    1984-02-09
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