NDC 0517-0735

Nicardipine Hydrochloride

Nicardipine Hydrochloride

Nicardipine Hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Nicardipine Hydrochloride.

Product ID0517-0735_0b0224f0-1072-4149-b2ee-24bdb2832d01
NDC0517-0735
Product TypeHuman Prescription Drug
Proprietary NameNicardipine Hydrochloride
Generic NameNicardipine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-05-08
Marketing CategoryANDA / ANDA
Application NumberANDA090534
Labeler NameAmerican Regent, Inc.
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 Through2021-12-31

Packaging

NDC 0517-0735-10

10 VIAL in 1 CARTON (0517-0735-10) > 10 mL in 1 VIAL (0517-0735-01)
Marketing Start Date2020-05-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-0735-10 [00517073510]

Nicardipine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090534
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-08

NDC 0517-0735-01 [00517073501]

Nicardipine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090534
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-08

Drug Details

Active Ingredients

IngredientStrength
NICARDIPINE HYDROCHLORIDE2.5 mg/mL

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
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