eplerenone

Generic: eplerenone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eplerenone
Generic Name eplerenone
Labeler proficient rx lp
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

eplerenone 25 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-863
Product ID 71205-863_49b9759a-c1b9-4ebe-874b-81fb82a42755
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 71205863
Hyphenated Format 71205-863

Supplemental Identifiers

RxCUI
351256 351257
UPC
0371205863302 0371205864309
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
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-00)
  • 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-11)
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-30)
  • 500 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-55)
  • 60 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-60)
  • 120 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-72)
  • 180 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-78)
  • 90 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-90)
source: ndc

Packages (8)

71205-863-00 100 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-00) 71205-863-11 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-11) 71205-863-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-30) 71205-863-55 500 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-55) 71205-863-60 60 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-60) 71205-863-72 120 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-72) 71205-863-78 180 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-78) 71205-863-90 90 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-90)

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": "49b9759a-c1b9-4ebe-874b-81fb82a42755", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0371205863302", "0371205864309"], "unii": ["6995V82D0B"], "rxcui": ["351256", "351257"], "spl_set_id": ["49b9759a-c1b9-4ebe-874b-81fb82a42755"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-00)", "package_ndc": "71205-863-00", "marketing_start_date": "20220324"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-11)", "package_ndc": "71205-863-11", "marketing_start_date": "20220324"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-30)", "package_ndc": "71205-863-30", "marketing_start_date": "20220324"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-55)", "package_ndc": "71205-863-55", "marketing_start_date": "20220324"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-60)", "package_ndc": "71205-863-60", "marketing_start_date": "20220324"}, {"sample": false, "description": "120 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-72)", "package_ndc": "71205-863-72", "marketing_start_date": "20220324"}, {"sample": false, "description": "180 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-78)", "package_ndc": "71205-863-78", "marketing_start_date": "20220324"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-90)", "package_ndc": "71205-863-90", "marketing_start_date": "20220324"}], "brand_name": "Eplerenone", "product_id": "71205-863_49b9759a-c1b9-4ebe-874b-81fb82a42755", "dosage_form": "TABLET, COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "71205-863", "generic_name": "Eplerenone", "labeler_name": "Proficient Rx LP", "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"}