spironolactone

Generic: spironolactone

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler a-s medication solutions
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

spironolactone 25 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6369
Product ID 50090-6369_5cfdfcdf-5472-4384-a651-b8d4f65a19f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040750
Listing Expiration 2026-12-31
Marketing Start 2021-01-04

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 500906369
Hyphenated Format 50090-6369

Supplemental Identifiers

RxCUI
313096
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 ANDA040750 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (50090-6369-0)
  • 30 TABLET, COATED in 1 BOTTLE (50090-6369-1)
  • 90 TABLET, COATED in 1 BOTTLE (50090-6369-6)
source: ndc

Packages (3)

50090-6369-0 100 TABLET, COATED in 1 BOTTLE (50090-6369-0) 50090-6369-1 30 TABLET, COATED in 1 BOTTLE (50090-6369-1) 50090-6369-6 90 TABLET, COATED in 1 BOTTLE (50090-6369-6)

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": "5cfdfcdf-5472-4384-a651-b8d4f65a19f7", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["313096"], "spl_set_id": ["bb29ea6f-c294-4895-9e9b-544d69651a35"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (50090-6369-0)", "package_ndc": "50090-6369-0", "marketing_start_date": "20230210"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (50090-6369-1)", "package_ndc": "50090-6369-1", "marketing_start_date": "20230216"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (50090-6369-6)", "package_ndc": "50090-6369-6", "marketing_start_date": "20230216"}], "brand_name": "Spironolactone", "product_id": "50090-6369_5cfdfcdf-5472-4384-a651-b8d4f65a19f7", "dosage_form": "TABLET, COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "50090-6369", "generic_name": "Spironolactone", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/1"}], "application_number": "ANDA040750", "marketing_category": "ANDA", "marketing_start_date": "20210104", "listing_expiration_date": "20261231"}