spironolactone

Generic: spironolactone

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

Drug Facts

Product Profile

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

spironolactone 100 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4447
Product ID 70518-4447_3cbc69e9-2f60-c617-e063-6294a90a1df4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202187
Listing Expiration 2026-12-31
Marketing Start 2025-08-19

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 705184447
Hyphenated Format 70518-4447

Supplemental Identifiers

RxCUI
198222
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
  • 100 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-4447-0) / 1 TABLET in 1 POUCH (70518-4447-1)
source: ndc

Packages (1)

70518-4447-0 100 POUCH in 1 BOX (70518-4447-0) / 1 TABLET in 1 POUCH (70518-4447-1)

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": "3cbc69e9-2f60-c617-e063-6294a90a1df4", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198222"], "spl_set_id": ["860b08bf-c6c1-4310-8510-10b6779f3d59"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-4447-0)  / 1 TABLET in 1 POUCH (70518-4447-1)", "package_ndc": "70518-4447-0", "marketing_start_date": "20250819"}], "brand_name": "SPIRONOLACTONE", "product_id": "70518-4447_3cbc69e9-2f60-c617-e063-6294a90a1df4", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "70518-4447", "generic_name": "SPIRONOLACTONE", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SPIRONOLACTONE", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "100 mg/1"}], "application_number": "ANDA202187", "marketing_category": "ANDA", "marketing_start_date": "20250819", "listing_expiration_date": "20261231"}