eplerenone

Generic: eplerenone

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

eplerenone 50 mg/1

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-294
Product ID 16729-294_411f4c8e-931e-612c-e063-6294a90a2885
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206922
Listing Expiration 2026-12-31
Marketing Start 2018-10-09

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 16729294
Hyphenated Format 16729-294

Supplemental Identifiers

RxCUI
351256 351257
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 ANDA206922 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (16729-294-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (16729-294-15)
source: ndc

Packages (2)

16729-294-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-294-10) 16729-294-15 90 TABLET, FILM COATED in 1 BOTTLE (16729-294-15)

Ingredients (1)

eplerenone (50 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": "411f4c8e-931e-612c-e063-6294a90a2885", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["6995V82D0B"], "rxcui": ["351256", "351257"], "spl_set_id": ["b0886e4e-5710-4053-9270-4d7de34068e7"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16729-294-10)", "package_ndc": "16729-294-10", "marketing_start_date": "20181009"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16729-294-15)", "package_ndc": "16729-294-15", "marketing_start_date": "20181009"}], "brand_name": "Eplerenone", "product_id": "16729-294_411f4c8e-931e-612c-e063-6294a90a2885", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "16729-294", "generic_name": "Eplerenone", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eplerenone", "active_ingredients": [{"name": "EPLERENONE", "strength": "50 mg/1"}], "application_number": "ANDA206922", "marketing_category": "ANDA", "marketing_start_date": "20181009", "listing_expiration_date": "20261231"}