NDC 0832-0480

Eplerenone

Eplerenone

Eplerenone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Eplerenone.

• Product ID: 0832-0480_3e83bc5f-8d57-4af9-b7a0-58d11cb412de
• NDC: 0832-0480
• Product Type: Human Prescription Drug
• Proprietary Name: Eplerenone
• Generic Name: Eplerenone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-03-16
• Marketing End Date: 2021-10-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078510
• Labeler Name: Upsher-Smith Laboratories, LLC
• Substance Name: EPLERENONE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0832-0480-30

30 TABLET in 1 BOTTLE (0832-0480-30)

• Marketing Start Date: 2015-03-16
• Marketing End Date: 2021-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0832-0480-30 [00832048030]

Eplerenone TABLET

• Marketing Category: ANDA
• Application Number: ANDA078510
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-16

NDC 0832-0480-90 [00832048090]

Eplerenone TABLET

• Marketing Category: ANDA
• Application Number: ANDA078510
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-16

Drug Details

Active Ingredients

Ingredient	Strength
EPLERENONE	25 mg/1

OpenFDA Data

• SPL SET ID: 84babd0d-cb0e-4292-bf45-8883a5ab5500
• Manufacturer:
  • Upsher-Smith Laboratories, LLC
• UNII:
  • 6995V82D0B
• RxNorm Concept Unique ID - RxCUI:
  • 351256
  • 351257

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
68084-948	Eplerenone	Eplerenone
59762-1720	Eplerenone	Eplerenone
60505-2652	Eplerenone	Eplerenone
60505-2651	Eplerenone	Eplerenone
60687-451	EPLERENONE	EPLERENONE
70436-098	eplerenone	eplerenone
70436-099	eplerenone	eplerenone
0025-1710	Inspra	eplerenone
0025-1720	Inspra	eplerenone
21695-797	Inspra	eplerenone