spironolactone

Generic: spironolactone

Labeler: jubilant cadista pharmacuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler jubilant cadista pharmacuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 100 mg/1

Manufacturer
Jubilant Cadista Pharmacuticals Inc.

Identifiers & Regulatory

Product NDC 59746-218
Product ID 59746-218_c1c5fdab-3ff7-414b-8e25-beed8311b8ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203253
Listing Expiration 2026-12-31
Marketing Start 2013-02-01

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 59746218
Hyphenated Format 59746-218

Supplemental Identifiers

RxCUI
198222 198223 313096
UPC
0359746217068 0359746218065 0359746216061
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 ANDA203253 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (59746-218-06)
  • 500 TABLET, FILM COATED in 1 BOTTLE (59746-218-09)
source: ndc

Packages (2)

59746-218-06 100 TABLET, FILM COATED in 1 BOTTLE (59746-218-06) 59746-218-09 500 TABLET, FILM COATED in 1 BOTTLE (59746-218-09)

Ingredients (1)

spironolactone (100 mg/1)

Linked Drug Pages (2)

Spironolactone ndc-match (0.9) Spironolactone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c1c5fdab-3ff7-414b-8e25-beed8311b8ad", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0359746217068", "0359746218065", "0359746216061"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["c1c5fdab-3ff7-414b-8e25-beed8311b8ad"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Jubilant Cadista Pharmacuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (59746-218-06)", "package_ndc": "59746-218-06", "marketing_start_date": "20170404"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (59746-218-09)", "package_ndc": "59746-218-09", "marketing_start_date": "20170404"}], "brand_name": "Spironolactone", "product_id": "59746-218_c1c5fdab-3ff7-414b-8e25-beed8311b8ad", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "59746-218", "generic_name": "spironolactone", "labeler_name": "Jubilant Cadista Pharmacuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "100 mg/1"}], "application_number": "ANDA203253", "marketing_category": "ANDA", "marketing_start_date": "20130201", "listing_expiration_date": "20261231"}