spironolactone

Generic: spironolactone

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 25 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-062
Product ID 76420-062_06c94882-1323-c834-e063-6394a90a2d75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203512
Listing Expiration 2026-12-31
Marketing Start 2017-06-02

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 76420062
Hyphenated Format 76420-062

Supplemental Identifiers

RxCUI
198223 313096
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 ANDA203512 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-062-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-062-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-062-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-062-90)
source: ndc

Packages (4)

76420-062-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-062-01) 76420-062-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-062-30) 76420-062-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-062-60) 76420-062-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-062-90)

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": "06c94882-1323-c834-e063-6394a90a2d75", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198223", "313096"], "spl_set_id": ["31c42b3e-f076-49d9-aa61-6cef0dbb5543"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-062-01)", "package_ndc": "76420-062-01", "marketing_start_date": "20231003"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-062-30)", "package_ndc": "76420-062-30", "marketing_start_date": "20200211"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-062-60)", "package_ndc": "76420-062-60", "marketing_start_date": "20231003"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-062-90)", "package_ndc": "76420-062-90", "marketing_start_date": "20231003"}], "brand_name": "Spironolactone", "product_id": "76420-062_06c94882-1323-c834-e063-6394a90a2d75", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "76420-062", "generic_name": "spironolactone", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/1"}], "application_number": "ANDA203512", "marketing_category": "ANDA", "marketing_start_date": "20170602", "listing_expiration_date": "20261231"}