eplerenone

Generic: eplerenone

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eplerenone
Generic Name eplerenone
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eplerenone 25 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-451
Product ID 60687-451_357fb20b-fdb4-58f9-e063-6394a90ae2a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208283
Listing Expiration 2026-12-31
Marketing Start 2019-06-13

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 60687451
Hyphenated Format 60687-451

Supplemental Identifiers

RxCUI
351256
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 ANDA208283 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-451-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-451-11)
source: ndc

Packages (1)

60687-451-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-451-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-451-11)

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": "357fb20b-fdb4-58f9-e063-6394a90ae2a7", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["6995V82D0B"], "rxcui": ["351256"], "spl_set_id": ["3a3047f2-0155-4a07-955f-839a312cf879"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-451-21)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-451-11)", "package_ndc": "60687-451-21", "marketing_start_date": "20190613"}], "brand_name": "EPLERENONE", "product_id": "60687-451_357fb20b-fdb4-58f9-e063-6394a90ae2a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "60687-451", "generic_name": "EPLERENONE", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPLERENONE", "active_ingredients": [{"name": "EPLERENONE", "strength": "25 mg/1"}], "application_number": "ANDA208283", "marketing_category": "ANDA", "marketing_start_date": "20190613", "listing_expiration_date": "20261231"}