eplerenone

Generic: eplerenone

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eplerenone
Generic Name eplerenone
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

eplerenone 50 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-174
Product ID 16571-174_9fdff54f-c6fc-4215-a611-5051a7fbae84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214663
Listing Expiration 2026-12-31
Marketing Start 2024-09-30

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 16571174
Hyphenated Format 16571-174

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 ANDA214663 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (16571-174-03)
  • 90 TABLET in 1 BOTTLE (16571-174-09)
source: ndc

Packages (2)

16571-174-03 30 TABLET in 1 BOTTLE (16571-174-03) 16571-174-09 90 TABLET in 1 BOTTLE (16571-174-09)

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": "9fdff54f-c6fc-4215-a611-5051a7fbae84", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["6995V82D0B"], "rxcui": ["351256", "351257"], "spl_set_id": ["9b66a393-8af1-42bc-9673-89fe471147ee"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (16571-174-03)", "package_ndc": "16571-174-03", "marketing_start_date": "20240930"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (16571-174-09)", "package_ndc": "16571-174-09", "marketing_start_date": "20240930"}], "brand_name": "Eplerenone", "product_id": "16571-174_9fdff54f-c6fc-4215-a611-5051a7fbae84", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "16571-174", "generic_name": "Eplerenone", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eplerenone", "active_ingredients": [{"name": "EPLERENONE", "strength": "50 mg/1"}], "application_number": "ANDA214663", "marketing_category": "ANDA", "marketing_start_date": "20240930", "listing_expiration_date": "20261231"}