spironolactone

Generic: spironolactone

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

spironolactone 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-291
Product ID 72789-291_43f46075-2020-1efb-e063-6394a90a42bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040750
Listing Expiration 2026-12-31
Marketing Start 2021-01-04

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 72789291
Hyphenated Format 72789-291

Supplemental Identifiers

RxCUI
198223
UPC
0372789291307
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 ANDA040750 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-30)
  • 60 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-60)
  • 500 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-82)
  • 90 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-90)
source: ndc

Packages (4)

72789-291-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-30) 72789-291-60 60 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-60) 72789-291-82 500 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-82) 72789-291-90 90 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-90)

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": "43f46075-2020-1efb-e063-6394a90a42bb", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0372789291307"], "unii": ["27O7W4T232"], "rxcui": ["198223"], "spl_set_id": ["8a66d90e-5450-4716-8c01-e7dc1967d00d"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-30)", "package_ndc": "72789-291-30", "marketing_start_date": "20221212"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-60)", "package_ndc": "72789-291-60", "marketing_start_date": "20221212"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-82)", "package_ndc": "72789-291-82", "marketing_start_date": "20221212"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-90)", "package_ndc": "72789-291-90", "marketing_start_date": "20221212"}], "brand_name": "Spironolactone", "product_id": "72789-291_43f46075-2020-1efb-e063-6394a90a42bb", "dosage_form": "TABLET, COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "72789-291", "generic_name": "Spironolactone", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "50 mg/1"}], "application_number": "ANDA040750", "marketing_category": "ANDA", "marketing_start_date": "20210104", "listing_expiration_date": "20261231"}