spironolactone

Generic: spironolactone

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

Drug Facts

Product Profile

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

spironolactone 50 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-514
Product ID 65162-514_8cdb3181-3666-48aa-a197-fb3a1e082e74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091426
Listing Expiration 2026-12-31
Marketing Start 2010-08-02

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 65162514
Hyphenated Format 65162-514

Supplemental Identifiers

RxCUI
198222 198223 313096
UPC
0365162515039 0365162511031 0365162514032
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 ANDA091426 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-514-03)
  • 60 TABLET in 1 BOTTLE (65162-514-06)
  • 90 TABLET in 1 BOTTLE (65162-514-09)
  • 100 TABLET in 1 BOTTLE (65162-514-10)
  • 1000 TABLET in 1 BOTTLE (65162-514-11)
  • 500 TABLET in 1 BOTTLE (65162-514-50)
  • 100 TABLET in 1 BLISTER PACK (65162-514-60)
source: ndc

Packages (7)

65162-514-03 30 TABLET in 1 BOTTLE (65162-514-03) 65162-514-06 60 TABLET in 1 BOTTLE (65162-514-06) 65162-514-09 90 TABLET in 1 BOTTLE (65162-514-09) 65162-514-10 100 TABLET in 1 BOTTLE (65162-514-10) 65162-514-11 1000 TABLET in 1 BOTTLE (65162-514-11) 65162-514-50 500 TABLET in 1 BOTTLE (65162-514-50) 65162-514-60 100 TABLET in 1 BLISTER PACK (65162-514-60)

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": "8cdb3181-3666-48aa-a197-fb3a1e082e74", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0365162515039", "0365162511031", "0365162514032"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["fb66327e-8261-46ae-b39a-4fa79d520844"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-514-03)", "package_ndc": "65162-514-03", "marketing_start_date": "20100802"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (65162-514-06)", "package_ndc": "65162-514-06", "marketing_start_date": "20100802"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-514-09)", "package_ndc": "65162-514-09", "marketing_start_date": "20100802"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (65162-514-10)", "package_ndc": "65162-514-10", "marketing_start_date": "20100802"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-514-11)", "package_ndc": "65162-514-11", "marketing_start_date": "20100802"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-514-50)", "package_ndc": "65162-514-50", "marketing_start_date": "20100802"}, {"sample": false, "description": "100 TABLET in 1 BLISTER PACK (65162-514-60)", "package_ndc": "65162-514-60", "marketing_start_date": "20100802"}], "brand_name": "Spironolactone", "product_id": "65162-514_8cdb3181-3666-48aa-a197-fb3a1e082e74", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "65162-514", "generic_name": "Spironolactone", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "50 mg/1"}], "application_number": "ANDA091426", "marketing_category": "ANDA", "marketing_start_date": "20100802", "listing_expiration_date": "20261231"}