eplerenone

Generic: eplerenone

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eplerenone
Generic Name eplerenone
Labeler avkare
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

eplerenone 50 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-455
Product ID 42291-455_485d3fe4-eadd-a4dc-e063-6294a90ab9f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207842
Listing Expiration 2027-12-31
Marketing Start 2022-03-03

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 42291455
Hyphenated Format 42291-455

Supplemental Identifiers

RxCUI
351256 351257
UNII
6995V82D0B
NUI
N0000175557 N0000011310

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
  • 50 mg/1
source: ndc
Packaging
  • 90 TABLET, COATED in 1 BOTTLE (42291-455-90)
source: ndc

Packages (1)

42291-455-90 90 TABLET, COATED in 1 BOTTLE (42291-455-90)

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": "485d3fe4-eadd-a4dc-e063-6294a90ab9f0", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["6995V82D0B"], "rxcui": ["351256", "351257"], "spl_set_id": ["d953457e-0aff-6c38-e053-2995a90a7d32"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (42291-455-90)", "package_ndc": "42291-455-90", "marketing_start_date": "20220303"}], "brand_name": "Eplerenone", "product_id": "42291-455_485d3fe4-eadd-a4dc-e063-6294a90ab9f0", "dosage_form": "TABLET, COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "42291-455", "generic_name": "Eplerenone", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eplerenone", "active_ingredients": [{"name": "EPLERENONE", "strength": "50 mg/1"}], "application_number": "ANDA207842", "marketing_category": "ANDA", "marketing_start_date": "20220303", "listing_expiration_date": "20271231"}