NDC 21695-797

Inspra

Eplerenone

Inspra is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Eplerenone.

• Product ID: 21695-797_c7bc9486-8e61-4ba1-827f-2cd8c304b454
• NDC: 21695-797
• Product Type: Human Prescription Drug
• Proprietary Name: Inspra
• Generic Name: Eplerenone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2002-09-27
• Marketing Category: NDA / NDA
• Application Number: NDA021437
• Labeler Name: Rebel Distributors Corp
• Substance Name: EPLERENONE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-797-90

90 TABLET in 1 BOTTLE (21695-797-90)

• Marketing Start Date: 2002-09-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-797-90 [21695079790]

Inspra TABLET

• Marketing Category: NDA
• Application Number: NDA021437
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-09-27
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
EPLERENONE	25 mg/1

OpenFDA Data

• SPL SET ID: c7bc9486-8e61-4ba1-827f-2cd8c304b454
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • 6995V82D0B
• RxNorm Concept Unique ID - RxCUI:
  • 402106
  • 351256

Pharmacological Class

• Aldosterone Antagonist [EPC]
• Aldosterone Antagonists [MoA]

NDC Crossover Matching brand name "Inspra" or generic name "Eplerenone"

NDC	Brand Name	Generic Name
0025-1710	Inspra	eplerenone
0025-1720	Inspra	eplerenone
21695-797	Inspra	eplerenone
0185-5368	Eplerenone	Eplerenone
0185-5369	Eplerenone	Eplerenone
0378-1030	Eplerenone	eplerenone
0378-1031	Eplerenone	eplerenone
0832-0480	Eplerenone	Eplerenone
0832-0481	Eplerenone	Eplerenone
16729-293	Eplerenone	Eplerenone
16729-294	Eplerenone	Eplerenone
42254-011	Eplerenone	Eplerenone
42291-454	Eplerenone	Eplerenone
42291-455	Eplerenone	Eplerenone
51991-877	EPLERENONE	EPLERENONE
51991-878	EPLERENONE	EPLERENONE
59762-1710	Eplerenone	eplerenone