spironolactone

Generic: spironolactone

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 25 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6927
Product ID 0904-6927_c37ed479-700b-4d5c-b269-383f2d2f9fd5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205936
Listing Expiration 2026-12-31
Marketing Start 2018-08-15

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 09046927
Hyphenated Format 0904-6927

Supplemental Identifiers

RxCUI
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 ANDA205936 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6927-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6927-61 100 BLISTER PACK in 1 CARTON (0904-6927-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "c37ed479-700b-4d5c-b269-383f2d2f9fd5", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["313096"], "spl_set_id": ["0c45d793-6f2f-4622-b5ed-6875acfbc02b"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6927-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6927-61", "marketing_start_date": "20180815"}], "brand_name": "spironolactone", "product_id": "0904-6927_c37ed479-700b-4d5c-b269-383f2d2f9fd5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "0904-6927", "generic_name": "spironolactone", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/1"}], "application_number": "ANDA205936", "marketing_category": "ANDA", "marketing_start_date": "20180815", "listing_expiration_date": "20261231"}