spironolactone

Generic: spironolactone

Labeler: oxford pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler oxford pharmaceuticals, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

spironolactone 100 mg/1

Manufacturer
Oxford Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69584-854
Product ID 69584-854_70be7336-8f41-4960-b57d-7830ca020481
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040750
Listing Expiration 2027-12-31
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 69584854
Hyphenated Format 69584-854

Supplemental Identifiers

RxCUI
198222 198223 313096
UNII
27O7W4T232
NUI
N0000175557 N0000011310

Packaging Origin

Original Packager
true

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
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET, COATED in 1 BOTTLE (69584-854-09)
  • 100 TABLET, COATED in 1 BOTTLE (69584-854-10)
  • 500 TABLET, COATED in 1 BOTTLE (69584-854-50)
  • 1000 TABLET, COATED in 1 BOTTLE (69584-854-90)
source: ndc

Packages (4)

69584-854-09 90 TABLET, COATED in 1 BOTTLE (69584-854-09) 69584-854-10 100 TABLET, COATED in 1 BOTTLE (69584-854-10) 69584-854-50 500 TABLET, COATED in 1 BOTTLE (69584-854-50) 69584-854-90 1000 TABLET, COATED in 1 BOTTLE (69584-854-90)

Ingredients (1)

spironolactone (100 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": "70be7336-8f41-4960-b57d-7830ca020481", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["852684dc-e1c6-4caa-bccb-10ac90bbb3bb"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Oxford Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (69584-854-09)", "package_ndc": "69584-854-09", "marketing_start_date": "20260217"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (69584-854-10)", "package_ndc": "69584-854-10", "marketing_start_date": "20210104"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (69584-854-50)", "package_ndc": "69584-854-50", "marketing_start_date": "20210104"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (69584-854-90)", "package_ndc": "69584-854-90", "marketing_start_date": "20240401"}], "brand_name": "Spironolactone", "product_id": "69584-854_70be7336-8f41-4960-b57d-7830ca020481", "dosage_form": "TABLET, COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "69584-854", "generic_name": "Spironolactone", "labeler_name": "Oxford Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "100 mg/1"}], "application_number": "ANDA040750", "marketing_category": "ANDA", "marketing_start_date": "20210104", "listing_expiration_date": "20271231"}