NDC 0143-9633

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 ID: 0143-9633_441a9565-d5ec-4727-9693-4d3112c07b3e
• NDC: 0143-9633
• Product Type: Human Prescription Drug
• Proprietary Name: Nicardipine Hydrochloride
• Generic Name: Nicardipine Hydrochloride
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-04-07
• Marketing Category: NDA / NDA
• Application Number: NDA022276
• Labeler Name: Hikma Pharmaceuticals USA Inc.
• Substance Name: NICARDIPINE HYDROCHLORIDE
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: Calcium 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 Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0143-9633-10

10 BAG in 1 CARTON (0143-9633-10) > 200 mL in 1 BAG (0143-9633-01)

• Marketing Start Date: 2016-04-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0143-9633-10 [00143963310]

Nicardipine Hydrochloride INJECTION

• Marketing Category: NDA
• Application Number: NDA022276
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-04-07

NDC 0143-9633-01 [00143963301]

Nicardipine Hydrochloride INJECTION

• Marketing Category: NDA
• Application Number: NDA022276
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-04-07

Drug Details

Active Ingredients

Ingredient	Strength
NICARDIPINE HYDROCHLORIDE	.2 mg/mL

OpenFDA Data

• SPL SET ID: 18fb1c2b-0c1e-436c-a5b6-d4840b5da228
• Manufacturer:
  • Hikma Pharmaceuticals USA Inc.
• UNII:
  • K5BC5011K3
• RxNorm Concept Unique ID - RxCUI:
  • 858607
  • 858599
  • 858603

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"

NDC	Brand Name	Generic Name
0143-9542	Nicardipine Hydrochloride	Nicardipine Hydrochloride
0143-9593	Nicardipine Hydrochloride	Nicardipine Hydrochloride
0143-9633	Nicardipine Hydrochloride	Nicardipine Hydrochloride
0143-9634	Nicardipine Hydrochloride	Nicardipine Hydrochloride
0143-9689	Nicardipine Hydrochloride	Nicardipine Hydrochloride
0378-1020	Nicardipine Hydrochloride	nicardipine hydrochloride
0378-1430	Nicardipine Hydrochloride	nicardipine hydrochloride
0517-0735	Nicardipine Hydrochloride	nicardipine hydrochloride
0781-3204	Nicardipine Hydrochloride	Nicardipine Hydrochloride
0781-9324	Nicardipine Hydrochloride	Nicardipine Hydrochloride
14593-124	Nicardipine Hydrochloride	Nicardipine Hydrochloride
24658-750	Nicardipine Hydrochloride	Nicardipine Hydrochloride
24658-751	Nicardipine Hydrochloride	Nicardipine Hydrochloride
40042-047	Nicardipine Hydrochloride	Nicardipine Hydrochloride
42806-501	Nicardipine Hydrochloride	Nicardipine Hydrochloride
42806-502	Nicardipine Hydrochloride	Nicardipine Hydrochloride
68151-0093	Nicardipine Hydrochloride	Nicardipine Hydrochloride
68151-0092	Nicardipine Hydrochloride	Nicardipine Hydrochloride
55648-631	Nicardipine Hydrochloride	Nicardipine Hydrochloride
64679-631	Nicardipine Hydrochloride	Nicardipine Hydrochloride
51662-1428	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE
51662-1482	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE
72572-470	Nicardipine Hydrochloride	Nicardipine Hydrochloride
10122-313	Cardene IV	nicardipine hydrochloride
10122-314	Cardene IV	nicardipine hydrochloride
10122-325	Cardene IV	nicardipine hydrochloride
43066-009	CARDENE IV	nicardipine hydrochloride
43066-016	CARDENE IV	nicardipine hydrochloride
43066-021	Cardene IV	nicardipine hydrochloride