SPIRONOLACTONE
These highlights do not include all the information needed to use SPIRONOLACTONE ORAL SUSPENSION safely and effectively. See full prescribing information for SPIRONOLACTONE ORAL SUSPENSION. SPIRONOLACTONE Oral SuspensionInitial U.S. Approval: 1960
Approved
Approval ID
522bd365-ddcc-48f4-8a98-66dc4c3bb314
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2023
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
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 Code0574-1133
Application NumberNDA209478
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateAugust 31, 2023
Generic Namespironolactone
INGREDIENTS (11)
spironolactoneActive
Quantity: 25 mg in 5 mL
Code: 27O7W4T232
Classification: ACTIB
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
sorbic acidInactive
Code: X045WJ989B
Classification: IACT
dimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
potassium sorbateInactive
Code: 1VPU26JZZ4
Classification: IACT
trisodium citrate dihydrateInactive
Code: B22547B95K
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT
ammonium glycyrrhizateInactive
Code: 3VRD35U26C
Classification: IACT