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, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 67544-310
Product ID 67544-310_3c92f359-98a1-43c4-b639-58ab3a388ab3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040424
Listing Expiration 2026-12-31
Marketing Start 1981-02-03

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 67544310
Hyphenated Format 67544-310

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 ANDA040424 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-45)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-60)
source: ndc

Packages (3)

67544-310-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-30) 67544-310-45 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-45) 67544-310-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-60)

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": "3c92f359-98a1-43c4-b639-58ab3a388ab3", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["313096"], "spl_set_id": ["1c97ce61-8e49-4724-a636-d179479d346c"], "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, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-30)", "package_ndc": "67544-310-30", "marketing_start_date": "20141219"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-45)", "package_ndc": "67544-310-45", "marketing_start_date": "20210909"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-60)", "package_ndc": "67544-310-60", "marketing_start_date": "20141219"}], "brand_name": "Spironolactone", "product_id": "67544-310_3c92f359-98a1-43c4-b639-58ab3a388ab3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "67544-310", "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": "ANDA040424", "marketing_category": "ANDA", "marketing_start_date": "19810203", "listing_expiration_date": "20261231"}