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 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-148
Product ID 71205-148_5857334b-cd0a-47c8-ba29-b8ba367162fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203512
Listing Expiration 2026-12-31
Marketing Start 2017-06-02

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 71205148
Hyphenated Format 71205-148

Supplemental Identifiers

RxCUI
198222 198223 313096
UPC
0371205148300 0371205147303 0371205146306
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 ANDA203512 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71205-148-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71205-148-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71205-148-90)
source: ndc

Packages (3)

71205-148-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-148-30) 71205-148-60 60 TABLET, FILM COATED in 1 BOTTLE (71205-148-60) 71205-148-90 90 TABLET, FILM COATED in 1 BOTTLE (71205-148-90)

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": "5857334b-cd0a-47c8-ba29-b8ba367162fa", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0371205148300", "0371205147303", "0371205146306"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["dffac5dc-a111-4095-a96c-54cc5c3866e5"], "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 (71205-148-30)", "package_ndc": "71205-148-30", "marketing_start_date": "20181101"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71205-148-60)", "package_ndc": "71205-148-60", "marketing_start_date": "20181101"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71205-148-90)", "package_ndc": "71205-148-90", "marketing_start_date": "20181101"}], "brand_name": "Spironolactone", "product_id": "71205-148_5857334b-cd0a-47c8-ba29-b8ba367162fa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "71205-148", "generic_name": "spironolactone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "100 mg/1"}], "application_number": "ANDA203512", "marketing_category": "ANDA", "marketing_start_date": "20170602", "listing_expiration_date": "20261231"}