spironolactone

Generic: spironolactone

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

spironolactone 50 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-707
Product ID 64980-707_198e8618-c012-4f1c-9365-84c1829893c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219494
Listing Expiration 2026-12-31
Marketing Start 2025-09-15

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 64980707
Hyphenated Format 64980-707

Supplemental Identifiers

RxCUI
198222 198223 313096
UNII
27O7W4T232
NUI
N0000175557 N0000011310

Packaging Origin

Original Packager
true

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 ANDA219494 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64980-707-01)
  • 500 TABLET in 1 BOTTLE (64980-707-50)
source: ndc

Packages (2)

64980-707-01 100 TABLET in 1 BOTTLE (64980-707-01) 64980-707-50 500 TABLET in 1 BOTTLE (64980-707-50)

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": "198e8618-c012-4f1c-9365-84c1829893c0", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["ac487ae2-e15f-4781-bae3-a03058cfcfe4"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64980-707-01)", "package_ndc": "64980-707-01", "marketing_start_date": "20250915"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (64980-707-50)", "package_ndc": "64980-707-50", "marketing_start_date": "20250915"}], "brand_name": "Spironolactone", "product_id": "64980-707_198e8618-c012-4f1c-9365-84c1829893c0", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "64980-707", "generic_name": "Spironolactone", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "50 mg/1"}], "application_number": "ANDA219494", "marketing_category": "ANDA", "marketing_start_date": "20250915", "listing_expiration_date": "20261231"}