spironolactone

Generic: spironolactone

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 25 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-5517
Product ID 55154-5517_a9817df4-41df-499d-9d7d-46daee4e514e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040424
Listing Expiration 2026-12-31
Marketing Start 2011-02-04

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 551545517
Hyphenated Format 55154-5517

Supplemental Identifiers

RxCUI
313096
UPC
0055154551700
UNII
27O7W4T232
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 spironolactone (source: ndc)
Generic Name spironolactone (source: ndc)
Application Number ANDA040424 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-5517-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-5517-0 10 BLISTER PACK in 1 BAG (55154-5517-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

spironolactone (25 mg/1)

Linked Drug Pages (1)

Spironolactone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a9817df4-41df-499d-9d7d-46daee4e514e", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0055154551700"], "unii": ["27O7W4T232"], "rxcui": ["313096"], "spl_set_id": ["48115c9e-c82f-438d-b178-dce1b73687db"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-5517-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-5517-0", "marketing_start_date": "20110204"}], "brand_name": "Spironolactone", "product_id": "55154-5517_a9817df4-41df-499d-9d7d-46daee4e514e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "55154-5517", "generic_name": "spironolactone", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/1"}], "application_number": "ANDA040424", "marketing_category": "ANDA", "marketing_start_date": "20110204", "listing_expiration_date": "20261231"}