spironolactone

Generic: spironolactone

Labeler: pharmpak, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler pharmpak, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

spironolactone 50 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-340
Product ID 54348-340_eb00ddbc-db02-8bba-e053-2a95a90af70c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091426
Listing Expiration 2026-12-31
Marketing Start 2019-07-09

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 54348340
Hyphenated Format 54348-340

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 ANDA091426 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-340-90) / 90 TABLET in 1 BOTTLE
source: ndc

Packages (1)

54348-340-90 1 BOTTLE in 1 BOX (54348-340-90) / 90 TABLET in 1 BOTTLE

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": "eb00ddbc-db02-8bba-e053-2a95a90af70c", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198223"], "spl_set_id": ["c450e66a-0f05-445e-b1df-df2b17a2f064"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-340-90)  / 90 TABLET in 1 BOTTLE", "package_ndc": "54348-340-90", "marketing_start_date": "20190709"}], "brand_name": "Spironolactone", "product_id": "54348-340_eb00ddbc-db02-8bba-e053-2a95a90af70c", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "54348-340", "generic_name": "SPIRONOLACTONE", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "50 mg/1"}], "application_number": "ANDA091426", "marketing_category": "ANDA", "marketing_start_date": "20190709", "listing_expiration_date": "20261231"}