NDC 0185-5369

Eplerenone

Eplerenone

Eplerenone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Eon Labs, Inc.. The primary component is Eplerenone.

• Product ID: 0185-5369_697e0d84-e7d2-400e-baab-2ca055e4c6a4
• NDC: 0185-5369
• Product Type: Human Prescription Drug
• Proprietary Name: Eplerenone
• Generic Name: Eplerenone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2008-08-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078510
• Labeler Name: Eon Labs, Inc.
• Substance Name: EPLERENONE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0185-5369-09

90 TABLET in 1 BOTTLE (0185-5369-09)

• Marketing Start Date: 2008-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0185-5369-09 [00185536909]

Eplerenone TABLET

• Marketing Category: ANDA
• Application Number: ANDA078510
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-08-01

NDC 0185-5369-30 [00185536930]

Eplerenone TABLET

• Marketing Category: ANDA
• Application Number: ANDA078510
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-08-01

Drug Details

Active Ingredients

Ingredient	Strength
EPLERENONE	50 mg/1

OpenFDA Data

• SPL SET ID: cd6cbf0b-34b8-43aa-8037-360480a19cf8
• Manufacturer:
  • Eon Labs, Inc.
• UNII:
  • 6995V82D0B
• RxNorm Concept Unique ID - RxCUI:
  • 351256
  • 351257
• UPC Code:
  • 0301855368308
  • 0301855369305

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