NDC 0378-1031

Eplerenone

Eplerenone

Eplerenone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Eplerenone.

• Product ID: 0378-1031_c5bb2ccf-435b-4111-a2fc-da914844788c
• NDC: 0378-1031
• Product Type: Human Prescription Drug
• Proprietary Name: Eplerenone
• Generic Name: Eplerenone
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-10-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203896
• Labeler Name: Mylan Pharmaceuticals 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: 2020-12-31

Packaging

NDC 0378-1031-77

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1031-77)

• Marketing Start Date: 2017-10-03
• Marketing End Date: 2022-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-1031-93 [00378103193]

Eplerenone TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA203896
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-03

NDC 0378-1031-77 [00378103177]

Eplerenone TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA203896
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-03

Drug Details

Active Ingredients

Ingredient	Strength
EPLERENONE	50 mg/1

OpenFDA Data

• SPL SET ID: a3f4afdc-0620-4899-ab4f-168fbfa446a8
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 6995V82D0B
• RxNorm Concept Unique ID - RxCUI:
  • 351256
  • 351257
• UPC Code:
  • 0303781030939

Pharmacological Class

• 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