NDC 0677-1978

Nisoldipine

Nisoldipine

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

• Product ID: 0677-1978_64a32a66-e695-4fa9-b0e3-df33d91ffc4f
• NDC: 0677-1978
• 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: 2009-09-01
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA020356
• Labeler Name: United Research Laboratories, Inc.
• Substance Name: NISOLDIPINE
• Active Ingredient Strength: 9 mg/1
• Pharm Classes: Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 0677-1978-01

1 BOTTLE in 1 CARTON (0677-1978-01) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

• Marketing Start Date: 2009-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0677-1978-01 [00677197801]

Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA authorized generic
• Application Number: NDA020356
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-09-01
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
NISOLDIPINE	8.5 mg/1

OpenFDA Data

• SPL SET ID: 2abc5435-b2ca-4e08-89bc-ab7526781819
• Manufacturer:
  • United Research Laboratories, Inc.
• UNII:
  • 4I8HAB65SZ
• RxNorm Concept Unique ID - RxCUI:
  • 763574
  • 790489
  • 763589
  • 763519

Pharmacological Class

• 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