NDC 0378-2222

Nisoldipine

Nisoldipine

Nisoldipine is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Nisoldipine.

• Product ID: 0378-2222_c1d7747e-abdf-4cf7-b286-217fc9a86c80
• NDC: 0378-2222
• Product Type: Human Prescription Drug
• Proprietary Name: Nisoldipine
• Generic Name: Nisoldipine
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2008-07-25
• Marketing End Date: 2030-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079051
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: NISOLDIPINE
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE]
• NDC Exclude Flag: N

Packaging

NDC 0378-2222-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2222-01)

• Marketing Start Date: 2008-07-25
• Marketing End Date: 2030-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-2222-01 [00378222201]

Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA079051
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-07-25

Drug Details

Active Ingredients

Ingredient	Strength
NISOLDIPINE	20 mg/1

OpenFDA Data

• SPL SET ID: a6a8a8ba-3966-4f37-a58b-44d3b05bdc4e
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 4I8HAB65SZ
• RxNorm Concept Unique ID - RxCUI:
  • 311984
  • 311985
  • 360344

Pharmacological Class

• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]
• Calcium Channel Antagonists [MoA]
• Decreased Blood Pressure [PE]
• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]
• Calcium Channel Antagonists [MoA]
• Decreased Blood Pressure [PE]

NDC Crossover Matching brand name "Nisoldipine" or generic name "Nisoldipine"

NDC	Brand Name	Generic Name
0378-2096	Nisoldipine	nisoldipine
0378-2097	Nisoldipine	nisoldipine
0378-2098	Nisoldipine	nisoldipine
0378-2099	Nisoldipine	nisoldipine
0378-2222	Nisoldipine	Nisoldipine
0378-2223	Nisoldipine	Nisoldipine
0378-2224	Nisoldipine	Nisoldipine
0677-1978	Nisoldipine	Nisoldipine
0677-1979	Nisoldipine	Nisoldipine
0677-1980	Nisoldipine	Nisoldipine
0677-1981	Nisoldipine	Nisoldipine
66993-472	Nisoldipine	Nisoldipine
66993-473	Nisoldipine	Nisoldipine
66993-475	Nisoldipine	Nisoldipine
59630-500	SULAR	Nisoldipine
59630-501	SULAR	Nisoldipine
59630-503	SULAR	Nisoldipine
70515-500	Sular	nisoldipine
70515-501	Sular	nisoldipine
70515-503	Sular	nisoldipine