spironolactone

Generic: spironolactone

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler padagis us llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

spironolactone 25 mg/5mL

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-1133
Product ID 0574-1133_902035fb-dba8-4fdf-9d8d-29d736c07d57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA209478
Listing Expiration 2026-12-31
Marketing Start 2023-10-31

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 05741133
Hyphenated Format 0574-1133

Supplemental Identifiers

RxCUI
104232
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 spironolactone (source: ndc)
Generic Name spironolactone (source: ndc)
Application Number NDA209478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (0574-1133-04)
  • 10 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10) / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05)
  • 473 mL in 1 BOTTLE (0574-1133-16)
source: ndc

Packages (3)

0574-1133-04 118 mL in 1 BOTTLE (0574-1133-04) 0574-1133-10 10 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10) / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05) 0574-1133-16 473 mL in 1 BOTTLE (0574-1133-16)

Ingredients (1)

spironolactone (25 mg/5mL)

Linked Drug Pages (1)

SPIRONOLACTONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "902035fb-dba8-4fdf-9d8d-29d736c07d57", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["104232"], "spl_set_id": ["522bd365-ddcc-48f4-8a98-66dc4c3bb314"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (0574-1133-04)", "package_ndc": "0574-1133-04", "marketing_start_date": "20231031"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10)  / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05)", "package_ndc": "0574-1133-10", "marketing_start_date": "20231031"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0574-1133-16)", "package_ndc": "0574-1133-16", "marketing_start_date": "20231031"}], "brand_name": "SPIRONOLACTONE", "product_id": "0574-1133_902035fb-dba8-4fdf-9d8d-29d736c07d57", "dosage_form": "SUSPENSION", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "0574-1133", "generic_name": "spironolactone", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SPIRONOLACTONE", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/5mL"}], "application_number": "NDA209478", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20231031", "listing_expiration_date": "20261231"}