spironolactone

Generic: spironolactone

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

spironolactone 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-102
Product ID 71610-102_c9e366cc-e9b4-4e14-8c40-8daf2fe265ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091426
Listing Expiration 2026-12-31
Marketing Start 2010-08-02

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 71610102
Hyphenated Format 71610-102

Supplemental Identifiers

RxCUI
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 ANDA091426 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (71610-102-60)
source: ndc

Packages (1)

71610-102-60 90 TABLET in 1 BOTTLE (71610-102-60)

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": "c9e366cc-e9b4-4e14-8c40-8daf2fe265ad", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["313096"], "spl_set_id": ["bf58378f-8304-4799-b0c0-fad8697149ab"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-102-60)", "package_ndc": "71610-102-60", "marketing_start_date": "20180726"}], "brand_name": "Spironolactone", "product_id": "71610-102_c9e366cc-e9b4-4e14-8c40-8daf2fe265ad", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "71610-102", "generic_name": "Spironolactone", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/1"}], "application_number": "ANDA091426", "marketing_category": "ANDA", "marketing_start_date": "20100802", "listing_expiration_date": "20261231"}