spironolactone

Generic: spironolactone

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 50 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-5341
Product ID 63629-5341_ed6e23ec-657b-4b09-a3a7-84174eb223e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089424
Listing Expiration 2026-12-31
Marketing Start 1986-07-23

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 636295341
Hyphenated Format 63629-5341

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 ANDA089424 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63629-5341-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63629-5341-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63629-5341-3)
  • 100 TABLET, FILM COATED in 1 BOTTLE (63629-5341-4)
  • 14 TABLET, FILM COATED in 1 BOTTLE (63629-5341-5)
  • 10 TABLET, FILM COATED in 1 BOTTLE (63629-5341-6)
source: ndc

Packages (6)

63629-5341-1 30 TABLET, FILM COATED in 1 BOTTLE (63629-5341-1) 63629-5341-2 60 TABLET, FILM COATED in 1 BOTTLE (63629-5341-2) 63629-5341-3 90 TABLET, FILM COATED in 1 BOTTLE (63629-5341-3) 63629-5341-4 100 TABLET, FILM COATED in 1 BOTTLE (63629-5341-4) 63629-5341-5 14 TABLET, FILM COATED in 1 BOTTLE (63629-5341-5) 63629-5341-6 10 TABLET, FILM COATED in 1 BOTTLE (63629-5341-6)

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": "ed6e23ec-657b-4b09-a3a7-84174eb223e9", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198223"], "spl_set_id": ["cae68fd6-5161-4650-bcde-6db98cbe6c8b"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63629-5341-1)", "package_ndc": "63629-5341-1", "marketing_start_date": "20140516"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63629-5341-2)", "package_ndc": "63629-5341-2", "marketing_start_date": "20171016"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63629-5341-3)", "package_ndc": "63629-5341-3", "marketing_start_date": "20160218"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (63629-5341-4)", "package_ndc": "63629-5341-4", "marketing_start_date": "20230309"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (63629-5341-5)", "package_ndc": "63629-5341-5", "marketing_start_date": "20230309"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (63629-5341-6)", "package_ndc": "63629-5341-6", "marketing_start_date": "20230309"}], "brand_name": "SPIRONOLACTONE", "product_id": "63629-5341_ed6e23ec-657b-4b09-a3a7-84174eb223e9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "63629-5341", "generic_name": "SPIRONOLACTONE", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SPIRONOLACTONE", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "50 mg/1"}], "application_number": "ANDA089424", "marketing_category": "ANDA", "marketing_start_date": "19860723", "listing_expiration_date": "20261231"}