spironolactone

Generic: spironolactone

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

spironolactone 25 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8451
Product ID 0615-8451_876a2024-3f0f-4afd-8229-4e05a6270315
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202187
Listing Expiration 2026-12-31
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 06158451
Hyphenated Format 0615-8451

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BLISTER PACK (0615-8451-05)
  • 30 TABLET in 1 BLISTER PACK (0615-8451-39)
source: ndc

Packages (2)

0615-8451-05 15 TABLET in 1 BLISTER PACK (0615-8451-05) 0615-8451-39 30 TABLET in 1 BLISTER PACK (0615-8451-39)

Ingredients (1)

spironolactone (25 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": "876a2024-3f0f-4afd-8229-4e05a6270315", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198223", "313096"], "spl_set_id": ["e34fc3ca-1272-446b-8dc2-25b62add01c3"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BLISTER PACK (0615-8451-05)", "package_ndc": "0615-8451-05", "marketing_start_date": "20230413"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8451-39)", "package_ndc": "0615-8451-39", "marketing_start_date": "20230413"}], "brand_name": "SPIRONOLACTONE", "product_id": "0615-8451_876a2024-3f0f-4afd-8229-4e05a6270315", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "0615-8451", "generic_name": "SPIRONOLACTONE", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SPIRONOLACTONE", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/1"}], "application_number": "ANDA202187", "marketing_category": "ANDA", "marketing_start_date": "20191213", "listing_expiration_date": "20261231"}