NDC 70515-500

Sular

Nisoldipine

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

• Product ID: 70515-500_45a7200c-e81a-4b29-835b-f98e36c2a4f6
• NDC: 70515-500
• Product Type: Human Prescription Drug
• Proprietary Name: Sular
• Generic Name: Nisoldipine
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-03
• Marketing Category: NDA / NDA
• Application Number: NDA020356
• Labeler Name: Covis Pharma
• 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: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70515-500-10

1 BOTTLE in 1 CARTON (70515-500-10) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

• Marketing Start Date: 2017-02-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70515-500-10 [70515050010]

Sular TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020356
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-03

Drug Details

Active Ingredients

Ingredient	Strength
NISOLDIPINE	8.5 mg/1

OpenFDA Data

• SPL SET ID: 589157fa-d129-4de3-be3d-e0e1c22c5873
• Manufacturer:
  • Covis Pharma
• UNII:
  • 4I8HAB65SZ
• RxNorm Concept Unique ID - RxCUI:
  • 790840
  • 790489
  • 763589
  • 763521
  • 763519
  • 763591

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
59630-500	SULAR	Nisoldipine
59630-501	SULAR	Nisoldipine
59630-503	SULAR	Nisoldipine
70515-500	Sular	nisoldipine
70515-501	Sular	nisoldipine
70515-503	Sular	nisoldipine
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