inspra

Generic: eplerenone

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name inspra
Generic Name eplerenone
Labeler viatris specialty llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eplerenone 50 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-143
Product ID 58151-143_77698b88-befe-44ae-b67d-03c56dcbbdf6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021437
Marketing Start 2024-09-17
Marketing End 2027-01-31

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 58151143
Hyphenated Format 58151-143

Supplemental Identifiers

RxCUI
351256 351257 402105 402106
UPC
0358151142934 0358151143931
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 inspra (source: ndc)
Generic Name eplerenone (source: ndc)
Application Number NDA021437 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (58151-143-93)
source: ndc

Packages (1)

58151-143-93 30 TABLET, FILM COATED in 1 BOTTLE (58151-143-93)

Ingredients (1)

eplerenone (50 mg/1)

Linked Drug Pages (1)

Inspra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "77698b88-befe-44ae-b67d-03c56dcbbdf6", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0358151142934", "0358151143931"], "unii": ["6995V82D0B"], "rxcui": ["351256", "351257", "402105", "402106"], "spl_set_id": ["1a52bedc-8e2c-4116-a296-a87770676b4a"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (58151-143-93)", "package_ndc": "58151-143-93", "marketing_end_date": "20270131", "marketing_start_date": "20240917"}], "brand_name": "Inspra", "product_id": "58151-143_77698b88-befe-44ae-b67d-03c56dcbbdf6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "58151-143", "generic_name": "eplerenone", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Inspra", "active_ingredients": [{"name": "EPLERENONE", "strength": "50 mg/1"}], "application_number": "NDA021437", "marketing_category": "NDA", "marketing_end_date": "20270131", "marketing_start_date": "20240917"}