NDC 0143-9689

Nicardipine Hydrochloride

Nicardipine Hydrochloride

Nicardipine Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Nicardipine Hydrochloride.

Product ID0143-9689_441a9565-d5ec-4727-9693-4d3112c07b3e
NDC0143-9689
Product TypeHuman Prescription Drug
Proprietary NameNicardipine Hydrochloride
Generic NameNicardipine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2012-03-02
Marketing CategoryNDA / NDA
Application NumberNDA022276
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameNICARDIPINE HYDROCHLORIDE
Active Ingredient Strength25 mg/10mL
Pharm ClassesCalcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0143-9689-10

10 VIAL in 1 CARTON (0143-9689-10) > 10 mL in 1 VIAL (0143-9689-01)
Marketing Start Date2012-03-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9689-01 [00143968901]

Nicardipine Hydrochloride INJECTION
Marketing CategoryNDA
Application NumberNDA022276
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-09-17

NDC 0143-9689-10 [00143968910]

Nicardipine Hydrochloride INJECTION
Marketing CategoryNDA
Application NumberNDA022276
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-03-02

Drug Details

Active Ingredients

IngredientStrength
NICARDIPINE HYDROCHLORIDE25 mg/10mL

OpenFDA Data

SPL SET ID:18fb1c2b-0c1e-436c-a5b6-d4840b5da228
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 858607

    • 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 "Nicardipine Hydrochloride" or generic name "Nicardipine Hydrochloride"

    NDCBrand NameGeneric Name
    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
    68151-0093Nicardipine HydrochlorideNicardipine Hydrochloride
    68151-0092Nicardipine HydrochlorideNicardipine Hydrochloride
    55648-631Nicardipine HydrochlorideNicardipine Hydrochloride
    64679-631Nicardipine HydrochlorideNicardipine Hydrochloride
    51662-1428NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE
    51662-1482NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE
    72572-470Nicardipine HydrochlorideNicardipine Hydrochloride
    10122-313Cardene IVnicardipine hydrochloride
    10122-314Cardene IVnicardipine hydrochloride
    10122-325Cardene IVnicardipine hydrochloride
    43066-009CARDENE IVnicardipine hydrochloride
    43066-016CARDENE IVnicardipine hydrochloride
    43066-021Cardene IVnicardipine hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.