spironolactone

Generic: spironolactone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 50 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-861
Product ID 63187-861_d5bfc979-a820-4d06-ab41-9ccbaf28a914
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203253
Listing Expiration 2026-12-31
Marketing Start 2013-02-01

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 63187861
Hyphenated Format 63187-861

Supplemental Identifiers

RxCUI
198223
UNII
27O7W4T232
NUI
N0000175557 N0000011310

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 ANDA203253 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-861-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-861-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-861-90)
source: ndc

Packages (3)

63187-861-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-861-30) 63187-861-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-861-60) 63187-861-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-861-90)

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": "d5bfc979-a820-4d06-ab41-9ccbaf28a914", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198223"], "spl_set_id": ["caf9c845-63eb-40bd-8261-0582abdf705a"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-861-30)", "package_ndc": "63187-861-30", "marketing_start_date": "20170601"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-861-60)", "package_ndc": "63187-861-60", "marketing_start_date": "20170601"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-861-90)", "package_ndc": "63187-861-90", "marketing_start_date": "20170601"}], "brand_name": "Spironolactone", "product_id": "63187-861_d5bfc979-a820-4d06-ab41-9ccbaf28a914", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "63187-861", "generic_name": "spironolactone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "50 mg/1"}], "application_number": "ANDA203253", "marketing_category": "ANDA", "marketing_start_date": "20130201", "listing_expiration_date": "20261231"}