eplerenone

Generic: eplerenone

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name eplerenone
Generic Name eplerenone
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eplerenone 25 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-1107
Product ID 59762-1107_b4bf45ee-6524-4a9d-9d7d-91886e32ee72
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021437
Listing Expiration 2026-12-31
Marketing Start 2024-12-13

Pharmacologic Class

Established (EPC)
aldosterone antagonist [epc]
Mechanism of Action
aldosterone antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597621107
Hyphenated Format 59762-1107

Supplemental Identifiers

RxCUI
351256 351257
UPC
0359762110725 0359762110817
UNII
6995V82D0B
NUI
N0000175557 N0000011310

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name eplerenone (source: ndc)
Generic Name eplerenone (source: ndc)
Application Number NDA021437 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (59762-1107-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (59762-1107-3)
source: ndc

Packages (2)

59762-1107-2 30 TABLET, FILM COATED in 1 BOTTLE (59762-1107-2) 59762-1107-3 90 TABLET, FILM COATED in 1 BOTTLE (59762-1107-3)

Ingredients (1)

eplerenone (25 mg/1)

Linked Drug Pages (1)

Eplerenone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b4bf45ee-6524-4a9d-9d7d-91886e32ee72", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0359762110725", "0359762110817"], "unii": ["6995V82D0B"], "rxcui": ["351256", "351257"], "spl_set_id": ["4286699b-2320-4d3d-831c-32085f36fb67"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59762-1107-2)", "package_ndc": "59762-1107-2", "marketing_start_date": "20241213"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (59762-1107-3)", "package_ndc": "59762-1107-3", "marketing_start_date": "20251024"}], "brand_name": "Eplerenone", "product_id": "59762-1107_b4bf45ee-6524-4a9d-9d7d-91886e32ee72", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "59762-1107", "generic_name": "eplerenone", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eplerenone", "active_ingredients": [{"name": "EPLERENONE", "strength": "25 mg/1"}], "application_number": "NDA021437", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20241213", "listing_expiration_date": "20261231"}