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 50 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6458
Product ID 50090-6458_17f7df99-eeea-4589-9c3e-5901a411447f
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 500906458
Hyphenated Format 50090-6458

Supplemental Identifiers

RxCUI
198223
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
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (50090-6458-0)
  • 90 TABLET, COATED in 1 BOTTLE (50090-6458-1)
  • 30 TABLET, COATED in 1 BOTTLE (50090-6458-2)
source: ndc

Packages (3)

50090-6458-0 100 TABLET, COATED in 1 BOTTLE (50090-6458-0) 50090-6458-1 90 TABLET, COATED in 1 BOTTLE (50090-6458-1) 50090-6458-2 30 TABLET, COATED in 1 BOTTLE (50090-6458-2)

Ingredients (1)

spironolactone (50 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": "17f7df99-eeea-4589-9c3e-5901a411447f", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198223"], "spl_set_id": ["c328f555-2da8-43ac-bc04-0e89d4d2aa53"], "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 (50090-6458-0)", "package_ndc": "50090-6458-0", "marketing_start_date": "20230501"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (50090-6458-1)", "package_ndc": "50090-6458-1", "marketing_start_date": "20230501"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (50090-6458-2)", "package_ndc": "50090-6458-2", "marketing_start_date": "20230501"}], "brand_name": "Spironolactone", "product_id": "50090-6458_17f7df99-eeea-4589-9c3e-5901a411447f", "dosage_form": "TABLET, COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "50090-6458", "generic_name": "Spironolactone", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "50 mg/1"}], "application_number": "ANDA040750", "marketing_category": "ANDA", "marketing_start_date": "20210104", "listing_expiration_date": "20261231"}