spironolactone

Generic: spironolactone

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 50 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-095
Product ID 31722-095_3d3f731e-28d0-d9b4-e063-6394a90ad1fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217761
Listing Expiration 2026-12-31
Marketing Start 2025-07-25

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 31722095
Hyphenated Format 31722-095

Supplemental Identifiers

RxCUI
198222 198223 313096
UPC
0331722096010 0331722094016
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 ANDA217761 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (31722-095-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (31722-095-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (31722-095-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-095-30)
source: ndc

Packages (4)

31722-095-01 100 TABLET, FILM COATED in 1 BOTTLE (31722-095-01) 31722-095-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-095-05) 31722-095-10 1000 TABLET, FILM COATED in 1 BOTTLE (31722-095-10) 31722-095-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-095-30)

Ingredients (1)

spironolactone (50 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": "3d3f731e-28d0-d9b4-e063-6394a90ad1fa", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0331722096010", "0331722094016"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["e61269b2-823a-49e8-b55f-ef0b8b1dbcde"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (31722-095-01)", "package_ndc": "31722-095-01", "marketing_start_date": "20250725"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (31722-095-05)", "package_ndc": "31722-095-05", "marketing_start_date": "20250725"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-095-10)", "package_ndc": "31722-095-10", "marketing_start_date": "20250725"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-095-30)", "package_ndc": "31722-095-30", "marketing_start_date": "20250725"}], "brand_name": "spironolactone", "product_id": "31722-095_3d3f731e-28d0-d9b4-e063-6394a90ad1fa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "31722-095", "generic_name": "spironolactone", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "50 mg/1"}], "application_number": "ANDA217761", "marketing_category": "ANDA", "marketing_start_date": "20250725", "listing_expiration_date": "20261231"}