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, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 100 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4512
Product ID 70518-4512_471a6338-2d90-bc84-e063-6394a90a6f3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205936
Listing Expiration 2026-12-31
Marketing Start 2025-10-28

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 705184512
Hyphenated Format 70518-4512

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 ANDA205936 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-4512-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4512-1)
source: ndc

Packages (1)

70518-4512-0 100 POUCH in 1 BOX (70518-4512-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4512-1)

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": "471a6338-2d90-bc84-e063-6394a90a6f3c", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198222"], "spl_set_id": ["8b76a904-6c99-485a-a05f-13a36c5f720c"], "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 (70518-4512-0)  / 1 TABLET, FILM COATED in 1 POUCH (70518-4512-1)", "package_ndc": "70518-4512-0", "marketing_start_date": "20251028"}], "brand_name": "spironolactone", "product_id": "70518-4512_471a6338-2d90-bc84-e063-6394a90a6f3c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "70518-4512", "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": "ANDA205936", "marketing_category": "ANDA", "marketing_start_date": "20251028", "listing_expiration_date": "20261231"}