spironolactone

Generic: spironolactone

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

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler mylan institutional inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 100 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-980
Product ID 51079-980_3a873ff3-7c53-afd9-e063-6294a90a155f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040424
Listing Expiration 2026-12-31
Marketing Start 2002-02-20

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 51079980
Hyphenated Format 51079-980

Supplemental Identifiers

RxCUI
198222 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 ANDA040424 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 80 BLISTER PACK in 1 CARTON (51079-980-08) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-980-01)
source: ndc

Packages (1)

51079-980-08 80 BLISTER PACK in 1 CARTON (51079-980-08) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-980-01)

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": "3a873ff3-7c53-afd9-e063-6294a90a155f", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["7e1a8152-941a-4aa4-bcb0-83c04905678f"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "80 BLISTER PACK in 1 CARTON (51079-980-08)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-980-01)", "package_ndc": "51079-980-08", "marketing_start_date": "20020220"}], "brand_name": "Spironolactone", "product_id": "51079-980_3a873ff3-7c53-afd9-e063-6294a90a155f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "51079-980", "generic_name": "spironolactone", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "100 mg/1"}], "application_number": "ANDA040424", "marketing_category": "ANDA", "marketing_start_date": "20020220", "listing_expiration_date": "20261231"}