spironolactone

Generic: spironolactone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler proficient rx lp
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

spironolactone 25 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-975
Product ID 82804-975_99b119e3-537a-464c-9376-4219bf283753
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 82804975
Hyphenated Format 82804-975

Supplemental Identifiers

RxCUI
198222 198223 313096
UPC
0382804977307 0382804975303 0382804976300
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 (82804-975-00)
  • 1000 TABLET, COATED in 1 BOTTLE (82804-975-11)
  • 30 TABLET, COATED in 1 BOTTLE (82804-975-30)
  • 500 TABLET, COATED in 1 BOTTLE (82804-975-55)
  • 60 TABLET, COATED in 1 BOTTLE (82804-975-60)
  • 120 TABLET, COATED in 1 BOTTLE (82804-975-72)
  • 90 TABLET, COATED in 1 BOTTLE (82804-975-90)
source: ndc

Packages (7)

82804-975-00 100 TABLET, COATED in 1 BOTTLE (82804-975-00) 82804-975-11 1000 TABLET, COATED in 1 BOTTLE (82804-975-11) 82804-975-30 30 TABLET, COATED in 1 BOTTLE (82804-975-30) 82804-975-55 500 TABLET, COATED in 1 BOTTLE (82804-975-55) 82804-975-60 60 TABLET, COATED in 1 BOTTLE (82804-975-60) 82804-975-72 120 TABLET, COATED in 1 BOTTLE (82804-975-72) 82804-975-90 90 TABLET, COATED in 1 BOTTLE (82804-975-90)

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": "99b119e3-537a-464c-9376-4219bf283753", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0382804977307", "0382804975303", "0382804976300"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["99b119e3-537a-464c-9376-4219bf283753"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (82804-975-00)", "package_ndc": "82804-975-00", "marketing_start_date": "20250213"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (82804-975-11)", "package_ndc": "82804-975-11", "marketing_start_date": "20250213"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (82804-975-30)", "package_ndc": "82804-975-30", "marketing_start_date": "20250213"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (82804-975-55)", "package_ndc": "82804-975-55", "marketing_start_date": "20250213"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (82804-975-60)", "package_ndc": "82804-975-60", "marketing_start_date": "20250213"}, {"sample": false, "description": "120 TABLET, COATED in 1 BOTTLE (82804-975-72)", "package_ndc": "82804-975-72", "marketing_start_date": "20250213"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (82804-975-90)", "package_ndc": "82804-975-90", "marketing_start_date": "20250213"}], "brand_name": "Spironolactone", "product_id": "82804-975_99b119e3-537a-464c-9376-4219bf283753", "dosage_form": "TABLET, COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "82804-975", "generic_name": "Spironolactone", "labeler_name": "Proficient Rx LP", "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"}