aldactone

Generic: spironolactone

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aldactone
Generic Name spironolactone
Labeler pfizer laboratories div pfizer inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 25 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0025-1001
Product ID 0025-1001_22946678-dcad-4518-9bc6-cbdf51a38c16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA012151
Listing Expiration 2026-12-31
Marketing Start 1960-01-21

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 00251001
Hyphenated Format 0025-1001

Supplemental Identifiers

RxCUI
198222 198223 200817 200820 200825 313096
UPC
0300251001314 0300251031311 0300251041310
UNII
27O7W4T232
NUI
N0000175557 N0000011310

Packaging Origin

Original Packager
true

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 aldactone (source: ndc)
Generic Name spironolactone (source: ndc)
Application Number NDA012151 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0025-1001-31)
source: ndc

Packages (1)

0025-1001-31 100 TABLET, FILM COATED in 1 BOTTLE (0025-1001-31)

Ingredients (1)

spironolactone (25 mg/1)

Linked Drug Pages (1)

Aldactone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "22946678-dcad-4518-9bc6-cbdf51a38c16", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0300251001314", "0300251031311", "0300251041310"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "200817", "200820", "200825", "313096"], "spl_set_id": ["0fed2822-3a03-4b64-9857-c682fcd462bc"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0025-1001-31)", "package_ndc": "0025-1001-31", "marketing_start_date": "19600121"}], "brand_name": "Aldactone", "product_id": "0025-1001_22946678-dcad-4518-9bc6-cbdf51a38c16", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "0025-1001", "generic_name": "spironolactone", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aldactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/1"}], "application_number": "NDA012151", "marketing_category": "NDA", "marketing_start_date": "19600121", "listing_expiration_date": "20261231"}