spironolactone

Generic: spironolactone

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

spironolactone 100 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-487
Product ID 60687-487_24ae6e13-ec56-15c1-e063-6394a90a8845
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205936
Listing Expiration 2026-12-31
Marketing Start 2019-06-06

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 60687487
Hyphenated Format 60687-487

Supplemental Identifiers

RxCUI
198222 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 ANDA205936 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-487-01) / 1 TABLET in 1 BLISTER PACK (60687-487-11)
source: ndc

Packages (1)

60687-487-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-487-01) / 1 TABLET in 1 BLISTER PACK (60687-487-11)

Ingredients (1)

spironolactone (100 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": "24ae6e13-ec56-15c1-e063-6394a90a8845", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["bd5ec154-b092-4c4d-8e72-ca2a2ef71a6d"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-487-01)  / 1 TABLET in 1 BLISTER PACK (60687-487-11)", "package_ndc": "60687-487-01", "marketing_start_date": "20190606"}], "brand_name": "Spironolactone", "product_id": "60687-487_24ae6e13-ec56-15c1-e063-6394a90a8845", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "60687-487", "generic_name": "Spironolactone", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "100 mg/1"}], "application_number": "ANDA205936", "marketing_category": "ANDA", "marketing_start_date": "20190606", "listing_expiration_date": "20261231"}