spironolactone

Generic: spironolactone

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler direct_rx
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

spironolactone 25 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-497
Product ID 72189-497_4c4b0c1a-d843-08bc-e063-6394a90ad546
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040750
Listing Expiration 2027-12-31
Marketing Start 2023-07-06

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 72189497
Hyphenated Format 72189-497

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 ANDA040750 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (72189-497-30)
  • 90 TABLET, COATED in 1 BOTTLE (72189-497-90)
source: ndc

Packages (2)

72189-497-30 30 TABLET, COATED in 1 BOTTLE (72189-497-30) 72189-497-90 90 TABLET, COATED in 1 BOTTLE (72189-497-90)

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": "4c4b0c1a-d843-08bc-e063-6394a90ad546", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["313096"], "spl_set_id": ["ffd2f3f5-c7c8-0028-e053-6394a90aaf17"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (72189-497-30)", "package_ndc": "72189-497-30", "marketing_start_date": "20230706"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (72189-497-90)", "package_ndc": "72189-497-90", "marketing_start_date": "20230706"}], "brand_name": "Spironolactone", "product_id": "72189-497_4c4b0c1a-d843-08bc-e063-6394a90ad546", "dosage_form": "TABLET, COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "72189-497", "generic_name": "Spironolactone", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/1"}], "application_number": "ANDA040750", "marketing_category": "ANDA", "marketing_start_date": "20230706", "listing_expiration_date": "20271231"}