spironolactone

Generic: spironolactone

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler amneal pharmaceuticals ny llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

spironolactone 25 mg/5mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2027
Product ID 69238-2027_e25b36dd-7948-4481-8994-13658f1f337f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215572
Listing Expiration 2026-12-31
Marketing Start 2023-09-08

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 692382027
Hyphenated Format 69238-2027

Supplemental Identifiers

RxCUI
104232
UPC
0369238202786
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 ANDA215572 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (69238-2027-2)
  • 118 mL in 1 BOTTLE (69238-2027-8)
source: ndc

Packages (2)

69238-2027-2 473 mL in 1 BOTTLE (69238-2027-2) 69238-2027-8 118 mL in 1 BOTTLE (69238-2027-8)

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": "e25b36dd-7948-4481-8994-13658f1f337f", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0369238202786"], "unii": ["27O7W4T232"], "rxcui": ["104232"], "spl_set_id": ["1ed9a2cb-d666-43db-b515-f9615fa6da25"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (69238-2027-2)", "package_ndc": "69238-2027-2", "marketing_start_date": "20230908"}, {"sample": false, "description": "118 mL in 1 BOTTLE (69238-2027-8)", "package_ndc": "69238-2027-8", "marketing_start_date": "20230908"}], "brand_name": "Spironolactone", "product_id": "69238-2027_e25b36dd-7948-4481-8994-13658f1f337f", "dosage_form": "SUSPENSION", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "69238-2027", "generic_name": "Spironolactone", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/5mL"}], "application_number": "ANDA215572", "marketing_category": "ANDA", "marketing_start_date": "20230908", "listing_expiration_date": "20261231"}