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 71610-742
Product ID 71610-742_affa2e96-25b1-435b-9668-82dcd7a5777e
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 71610742
Hyphenated Format 71610-742

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 ANDA089424 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (71610-742-30)
  • 45 TABLET in 1 BOTTLE, PLASTIC (71610-742-45)
  • 90 TABLET in 1 BOTTLE, PLASTIC (71610-742-60)
  • 180 TABLET in 1 BOTTLE, PLASTIC (71610-742-80)
source: ndc

Packages (4)

71610-742-30 30 TABLET in 1 BOTTLE, PLASTIC (71610-742-30) 71610-742-45 45 TABLET in 1 BOTTLE, PLASTIC (71610-742-45) 71610-742-60 90 TABLET in 1 BOTTLE, PLASTIC (71610-742-60) 71610-742-80 180 TABLET in 1 BOTTLE, PLASTIC (71610-742-80)

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": "affa2e96-25b1-435b-9668-82dcd7a5777e", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["313096"], "spl_set_id": ["fb961096-edbb-45ad-96b7-61c2f9b98cf9"], "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": "30 TABLET in 1 BOTTLE, PLASTIC (71610-742-30)", "package_ndc": "71610-742-30", "marketing_start_date": "20231026"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (71610-742-45)", "package_ndc": "71610-742-45", "marketing_start_date": "20231010"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71610-742-60)", "package_ndc": "71610-742-60", "marketing_start_date": "20231010"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (71610-742-80)", "package_ndc": "71610-742-80", "marketing_start_date": "20231010"}], "brand_name": "SPIRONOLACTONE", "product_id": "71610-742_affa2e96-25b1-435b-9668-82dcd7a5777e", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "71610-742", "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": "ANDA089424", "marketing_category": "ANDA", "marketing_start_date": "19860723", "listing_expiration_date": "20261231"}