NDC 0378-2096

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: 0378-2096_18276df2-9ea6-4560-b8fc-18b0d8025342
• NDC: 0378-2096
• 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: 2011-01-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091001
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: NISOLDIPINE
• Active Ingredient Strength: 9 mg/1
• Pharm Classes: Calcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0378-2096-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2096-01)

• Marketing Start Date: 2011-01-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-2096-01 [00378209601]

Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA091001
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-01-28

NDC 0378-2096-05 [00378209605]

Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA091001
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-01-28
• Marketing End Date: 2015-02-02

Drug Details

Active Ingredients

Ingredient	Strength
NISOLDIPINE	8.5 mg/1

OpenFDA Data

• SPL SET ID: 00d506a4-74d6-4838-b008-3f9e7c017e08
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 4I8HAB65SZ
• RxNorm Concept Unique ID - RxCUI:
  • 763574
  • 763519
  • 763589
  • 790489

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