Spironolactone
These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral useInitial U.S. Approval: 1960
Approved
Approval ID
5e456f3c-f93e-41c6-80c5-a737ed70feda
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 30, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Spironolactone
PRODUCT DETAILS
NDC Product Code68788-8452
Application NumberANDA040750
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 30, 2023
Generic NameSpironolactone
INGREDIENTS (13)
SpironolactoneActive
Quantity: 50 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Calcium Sulfate DihydrateInactive
Code: 4846Q921YM
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MintInactive
Code: FV98Z8GITP
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Povidone K30Inactive
Code: U725QWY32X
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT