NDC 55648-631

Nicardipine Hydrochloride

Nicardipine Hydrochloride

Nicardipine Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Nicardipine Hydrochloride.

Product ID55648-631_1aa072e3-8f11-4e34-8d13-bc0021f33713
NDC55648-631
Product TypeHuman Prescription Drug
Proprietary NameNicardipine Hydrochloride
Generic NameNicardipine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2009-11-09
Marketing CategoryANDA / ANDA
Application NumberANDA090671
Labeler NameWockhardt Limited
Substance NameNICARDIPINE HYDROCHLORIDE
Active Ingredient Strength3 mg/mL
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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55648-631-02

10 CARTON in 1 CARTON (55648-631-02) > 1 VIAL, SINGLE-DOSE in 1 CARTON (55648-631-01) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2009-11-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-631-02 [55648063102]

Nicardipine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA090671
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-09
Inactivation Date2020-01-31

NDC 55648-631-01 [55648063101]

Nicardipine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA090671
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-09

Drug Details

Active Ingredients

IngredientStrength
NICARDIPINE HYDROCHLORIDE2.5 mg/mL

OpenFDA Data

SPL SET ID:a6512740-17e0-4f22-a233-4ac084277879
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 858607
    • UPC Code
  • 0364679631010
  • 0364679631027

    • 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.