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 suspension Initial U.S. Approval: 1960
Approved
Approval ID
4ac2926a-949a-4383-b0b0-92c0822dfcda
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
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 Code31722-691
Application NumberANDA218085
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 8, 2025
Generic Namespironolactone
INGREDIENTS (13)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
DIMETHICONE, UNSPECIFIEDInactive
Code: 92RU3N3Y1O
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
SPIRONOLACTONEActive
Quantity: 25 mg in 5 mL
Code: 27O7W4T232
Classification: ACTIB