NDC 0025-1710

Inspra

Eplerenone

Inspra is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by G.d. Searle Llc Division Of Pfizer Inc. The primary component is Eplerenone.

• Product ID: 0025-1710_2afb151f-c6e2-48d5-8a0d-d266d17ffbec
• NDC: 0025-1710
• Product Type: Human Prescription Drug
• Proprietary Name: Inspra
• Generic Name: Eplerenone
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2002-09-27
• Marketing Category: NDA / NDA
• Application Number: NDA021437
• Labeler Name: G.D. Searle LLC Division of Pfizer Inc
• Substance Name: EPLERENONE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0025-1710-01

30 TABLET, FILM COATED in 1 BOTTLE (0025-1710-01)

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

NDC SPL Data Element Entries

NDC 0025-1710-01 [00025171001]

Inspra TABLET, FILM COATED

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

NDC 0025-1710-03 [00025171003]

Inspra TABLET, FILM COATED

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

NDC 0025-1710-02 [00025171002]

Inspra TABLET, FILM COATED

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

Drug Details

Active Ingredients

Ingredient	Strength
EPLERENONE	25 mg/1

OpenFDA Data

• SPL SET ID: a55a39ff-1bd5-428b-a64f-c44262e2f3ed
• Manufacturer:
  • G.D. Searle LLC Division of Pfizer Inc
• UNII:
  • 6995V82D0B
• RxNorm Concept Unique ID - RxCUI:
  • 402105
  • 402106
  • 351256
  • 351257
• UPC Code:
  • 0300251710018
  • 0300251720031

Pharmacological Class

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