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 SUSPENSION
Routes
ORAL
Active Ingredients

spironolactone 25 mg/5mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-691
Product ID 31722-691_3241a29b-82b9-fd3a-e063-6294a90aa46c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218085
Listing Expiration 2026-12-31
Marketing Start 2025-02-21

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 31722691
Hyphenated Format 31722-691

Supplemental Identifiers

RxCUI
104232
UPC
0331722691116 0331722691475
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 ANDA218085 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (31722-691-11)
  • 473 mL in 1 BOTTLE (31722-691-47)
source: ndc

Packages (2)

31722-691-11 118 mL in 1 BOTTLE (31722-691-11) 31722-691-47 473 mL in 1 BOTTLE (31722-691-47)

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": "3241a29b-82b9-fd3a-e063-6294a90aa46c", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0331722691116", "0331722691475"], "unii": ["27O7W4T232"], "rxcui": ["104232"], "spl_set_id": ["4ac2926a-949a-4383-b0b0-92c0822dfcda"], "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": "118 mL in 1 BOTTLE (31722-691-11)", "package_ndc": "31722-691-11", "marketing_start_date": "20250221"}, {"sample": false, "description": "473 mL in 1 BOTTLE (31722-691-47)", "package_ndc": "31722-691-47", "marketing_start_date": "20250221"}], "brand_name": "spironolactone", "product_id": "31722-691_3241a29b-82b9-fd3a-e063-6294a90aa46c", "dosage_form": "SUSPENSION", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "31722-691", "generic_name": "spironolactone", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/5mL"}], "application_number": "ANDA218085", "marketing_category": "ANDA", "marketing_start_date": "20250221", "listing_expiration_date": "20261231"}