Hydrocortisone Butyrate
These highlights do not include all the information needed to use HYDROCORTISONE BUTYRATE safely and effectively. See full prescribing information for HYDROCORTISONE BUTYRATE.Hydrocortisone Butyrate Lotion, 0.1%, for topical use Initial U.S. Approval: 1982
Approved
Approval ID
97d35248-b28b-18b0-98a6-2d93476fb4a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2017
Manufacturers
FDA
Teligent Pharma, Inc.
DUNS: 011036910
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROCORTISONE BUTYRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52565-087
Application NumberANDA209556
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCORTISONE BUTYRATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 10, 2019
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
HYDROCORTISONE BUTYRATEActive
Quantity: 1 mg in 1 mL
Code: 05RMF7YPWN
Classification: ACTIB
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT