eplerenone

Generic: eplerenone

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

eplerenone 50 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-050
Product ID 31722-050_fe285cf1-1e78-943b-e053-6394a90a760d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213812
Listing Expiration 2026-12-31
Marketing Start 2023-06-02

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 31722050
Hyphenated Format 31722-050

Supplemental Identifiers

RxCUI
351256 351257
UPC
0331722049306
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 ANDA213812 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-050-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (31722-050-90)
source: ndc

Packages (2)

31722-050-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-050-30) 31722-050-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-050-90)

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": "fe285cf1-1e78-943b-e053-6394a90a760d", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0331722049306"], "unii": ["6995V82D0B"], "rxcui": ["351256", "351257"], "spl_set_id": ["25a1c77c-7008-4b07-af14-5522a282783a"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-050-30)", "package_ndc": "31722-050-30", "marketing_start_date": "20230602"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (31722-050-90)", "package_ndc": "31722-050-90", "marketing_start_date": "20230602"}], "brand_name": "EPLERENONE", "product_id": "31722-050_fe285cf1-1e78-943b-e053-6394a90a760d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "31722-050", "generic_name": "EPLERENONE", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPLERENONE", "active_ingredients": [{"name": "EPLERENONE", "strength": "50 mg/1"}], "application_number": "ANDA213812", "marketing_category": "ANDA", "marketing_start_date": "20230602", "listing_expiration_date": "20261231"}