spironolactone

Generic: spironolactone

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

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

spironolactone 50 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8452
Product ID 68788-8452_54a64ac4-2d50-427f-a306-a2e705015502
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040750
Listing Expiration 2026-12-31
Marketing Start 2023-05-30

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 687888452
Hyphenated Format 68788-8452

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
  • 30 TABLET, COATED in 1 BOTTLE (68788-8452-3)
  • 60 TABLET, COATED in 1 BOTTLE (68788-8452-6)
  • 90 TABLET, COATED in 1 BOTTLE (68788-8452-9)
source: ndc

Packages (3)

68788-8452-3 30 TABLET, COATED in 1 BOTTLE (68788-8452-3) 68788-8452-6 60 TABLET, COATED in 1 BOTTLE (68788-8452-6) 68788-8452-9 90 TABLET, COATED in 1 BOTTLE (68788-8452-9)

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": "54a64ac4-2d50-427f-a306-a2e705015502", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198223"], "spl_set_id": ["5e456f3c-f93e-41c6-80c5-a737ed70feda"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (68788-8452-3)", "package_ndc": "68788-8452-3", "marketing_start_date": "20230530"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (68788-8452-6)", "package_ndc": "68788-8452-6", "marketing_start_date": "20230530"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (68788-8452-9)", "package_ndc": "68788-8452-9", "marketing_start_date": "20230530"}], "brand_name": "Spironolactone", "product_id": "68788-8452_54a64ac4-2d50-427f-a306-a2e705015502", "dosage_form": "TABLET, COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "68788-8452", "generic_name": "Spironolactone", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20230530", "listing_expiration_date": "20261231"}