CaroSpir
These highlights do not include all the information needed to use CAROSPIR safely and effectively. See full prescribing information for CAROSPIR. CAROSPIR (spironolactone) Oral Suspension, for oral useInitial U.S. Approval: 1960
Approved
Approval ID
c4f70a04-7d89-4b73-8b02-17d43471bf08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2023
Manufacturers
FDA
CMP Pharma, Inc.
DUNS: 005224175
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CaroSpir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46287-020
Application NumberNDA209478
Product Classification
M
Marketing Category
C73594
G
Generic Name
CaroSpir
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2021
FDA Product Classification
INGREDIENTS (11)
spironolactoneActive
Quantity: 25 mg in 5 mL
Code: 27O7W4T232
Classification: ACTIB
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
dimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
sorbic acidInactive
Code: X045WJ989B
Classification: IACT
potassium sorbateInactive
Code: 1VPU26JZZ4
Classification: IACT
saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
trisodium citrate dihydrateInactive
Code: B22547B95K
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
ammonium glycyrrhizateInactive
Code: 3VRD35U26C
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT