eplerenone

Generic: eplerenone

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

eplerenone 50 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-878
Product ID 51991-878_66d5298e-1841-47cc-9890-e3aec0d0a5a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208283
Listing Expiration 2026-12-31
Marketing Start 2018-09-18

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 51991878
Hyphenated Format 51991-878

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 ANDA208283 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (51991-878-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (51991-878-99)
  • 30 TABLET, FILM COATED in 1 BOTTLE (51991-878-33)
  • 90 TABLET, FILM COATED in 1 BOTTLE (51991-878-90)
source: ndc

Packages (3)

51991-878-11 10 BLISTER PACK in 1 CARTON (51991-878-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (51991-878-99) 51991-878-33 30 TABLET, FILM COATED in 1 BOTTLE (51991-878-33) 51991-878-90 90 TABLET, FILM COATED in 1 BOTTLE (51991-878-90)

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": "66d5298e-1841-47cc-9890-e3aec0d0a5a1", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["6995V82D0B"], "rxcui": ["351256", "351257"], "spl_set_id": ["e2a51c12-bdc2-4b3b-8e9e-bf363c2817ed"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (51991-878-11)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (51991-878-99)", "package_ndc": "51991-878-11", "marketing_start_date": "20180918"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (51991-878-33)", "package_ndc": "51991-878-33", "marketing_start_date": "20180918"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (51991-878-90)", "package_ndc": "51991-878-90", "marketing_start_date": "20180918"}], "brand_name": "EPLERENONE", "product_id": "51991-878_66d5298e-1841-47cc-9890-e3aec0d0a5a1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "51991-878", "generic_name": "EPLERENONE", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPLERENONE", "active_ingredients": [{"name": "EPLERENONE", "strength": "50 mg/1"}], "application_number": "ANDA208283", "marketing_category": "ANDA", "marketing_start_date": "20180918", "listing_expiration_date": "20261231"}