spironolactone

Generic: spironolactone

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

Drug Facts

Product Profile

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

spironolactone 100 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-515
Product ID 53746-515_0b757d66-e1f0-4d56-bbe0-2f0941f0a35e
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 53746515
Hyphenated Format 53746-515

Supplemental Identifiers

RxCUI
198222 198223 313096
UPC
0353746514301 0353746511300 0353746515308
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
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-515-01)
  • 500 TABLET in 1 BOTTLE (53746-515-05)
  • 1000 TABLET in 1 BOTTLE (53746-515-10)
  • 30 TABLET in 1 BOTTLE (53746-515-30)
  • 60 TABLET in 1 BOTTLE (53746-515-60)
  • 90 TABLET in 1 BOTTLE (53746-515-90)
source: ndc

Packages (6)

53746-515-01 100 TABLET in 1 BOTTLE (53746-515-01) 53746-515-05 500 TABLET in 1 BOTTLE (53746-515-05) 53746-515-10 1000 TABLET in 1 BOTTLE (53746-515-10) 53746-515-30 30 TABLET in 1 BOTTLE (53746-515-30) 53746-515-60 60 TABLET in 1 BOTTLE (53746-515-60) 53746-515-90 90 TABLET in 1 BOTTLE (53746-515-90)

Ingredients (1)

spironolactone (100 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": "0b757d66-e1f0-4d56-bbe0-2f0941f0a35e", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0353746514301", "0353746511300", "0353746515308"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["951b8948-dc0f-4aef-9910-82c252de936d"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-515-01)", "package_ndc": "53746-515-01", "marketing_start_date": "20100802"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-515-05)", "package_ndc": "53746-515-05", "marketing_start_date": "20100802"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-515-10)", "package_ndc": "53746-515-10", "marketing_start_date": "20100802"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (53746-515-30)", "package_ndc": "53746-515-30", "marketing_start_date": "20100802"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (53746-515-60)", "package_ndc": "53746-515-60", "marketing_start_date": "20100802"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (53746-515-90)", "package_ndc": "53746-515-90", "marketing_start_date": "20100802"}], "brand_name": "Spironolactone", "product_id": "53746-515_0b757d66-e1f0-4d56-bbe0-2f0941f0a35e", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "53746-515", "generic_name": "Spironolactone", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "100 mg/1"}], "application_number": "ANDA091426", "marketing_category": "ANDA", "marketing_start_date": "20100802", "listing_expiration_date": "20261231"}