U-Cort
U-cort (HYDROCORTISONE ACETATE CREAM USP, 1%)
Approved
Approval ID
1eb217be-34f1-4b3b-a3a5-4dfb83fb6143
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2020
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-3009
Application NumberANDA089472
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone Acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 31, 2020
FDA Product Classification
INGREDIENTS (13)
Hydrocortisone AcetateActive
Quantity: 10 mg in 1 g
Code: 3X7931PO74
Classification: ACTIB
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
isopropyl palmitateInactive
Code: 8CRQ2TH63M
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
sodium metabisulfiteInactive
Code: 4VON5FNS3C
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
trolamineInactive
Code: 9O3K93S3TK
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
ureaInactive
Code: 8W8T17847W
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT