spironolactone

Generic: spironolactone

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

spironolactone 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-428
Product ID 59651-428_9b6802a0-5117-4be3-a113-9098e8dcedaa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202187
Listing Expiration 2027-12-31
Marketing Start 2019-12-13

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 59651428
Hyphenated Format 59651-428

Supplemental Identifiers

RxCUI
198222 198223 313096
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 ANDA202187 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-428-01)
  • 500 TABLET in 1 BOTTLE (59651-428-05)
source: ndc

Packages (2)

59651-428-01 100 TABLET in 1 BOTTLE (59651-428-01) 59651-428-05 500 TABLET in 1 BOTTLE (59651-428-05)

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": "9b6802a0-5117-4be3-a113-9098e8dcedaa", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["768563dc-a619-44dc-b97f-1a7e71fd56a0"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-428-01)", "package_ndc": "59651-428-01", "marketing_start_date": "20191213"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (59651-428-05)", "package_ndc": "59651-428-05", "marketing_start_date": "20230824"}], "brand_name": "SPIRONOLACTONE", "product_id": "59651-428_9b6802a0-5117-4be3-a113-9098e8dcedaa", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "59651-428", "generic_name": "SPIRONOLACTONE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SPIRONOLACTONE", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "100 mg/1"}], "application_number": "ANDA202187", "marketing_category": "ANDA", "marketing_start_date": "20191213", "listing_expiration_date": "20271231"}