hydrocortisone and acetic acid
Hydrocortisone and Acetic Acid Otic Solution, USP
Approved
Approval ID
ffd1edc1-2f40-4b0a-a53a-9fb53b8d3184
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2022
Manufacturers
FDA
Akorn Operating Company LLC
DUNS: 117696873
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydrocortisone and acetic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-901
Application NumberNDA012770
Product Classification
M
Marketing Category
C73594
G
Generic Name
hydrocortisone and acetic acid
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (7)
ACETIC ACIDActive
Quantity: 20.75 mg in 1 mL
Code: Q40Q9N063P
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
BENZETHONIUM CHLORIDEInactive
Code: PH41D05744
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLENE GLYCOL DIACETATEInactive
Code: 5Z492UNF9O
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
HYDROCORTISONEActive
Quantity: 10.375 mg in 1 mL
Code: WI4X0X7BPJ
Classification: ACTIB