eplerenone

Generic: eplerenone

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eplerenone
Generic Name eplerenone
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

eplerenone 25 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-307
Product ID 69367-307_905d6ee4-8099-4afa-8535-a9511d468ccc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207842
Listing Expiration 2026-12-31
Marketing Start 2021-11-08

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 69367307
Hyphenated Format 69367-307

Supplemental Identifiers

RxCUI
351256 351257
UPC
0008080000064
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 ANDA207842 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 90 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-307-09)
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-307-30)
source: ndc

Packages (2)

69367-307-09 90 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-307-09) 69367-307-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-307-30)

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": "905d6ee4-8099-4afa-8535-a9511d468ccc", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0008080000064"], "unii": ["6995V82D0B"], "rxcui": ["351256", "351257"], "spl_set_id": ["316d3a98-4cd1-4499-a34c-cac87e016944"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-307-09)", "package_ndc": "69367-307-09", "marketing_start_date": "20211108"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-307-30)", "package_ndc": "69367-307-30", "marketing_start_date": "20211108"}], "brand_name": "Eplerenone", "product_id": "69367-307_905d6ee4-8099-4afa-8535-a9511d468ccc", "dosage_form": "TABLET, COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "69367-307", "generic_name": "Eplerenone", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eplerenone", "active_ingredients": [{"name": "EPLERENONE", "strength": "25 mg/1"}], "application_number": "ANDA207842", "marketing_category": "ANDA", "marketing_start_date": "20211108", "listing_expiration_date": "20261231"}