Hydrocortisone
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%
Approved
Approval ID
eb0b48d9-edeb-432c-836c-080ebce97c70
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 26, 2018
Manufacturers
FDA
Central Texas Community Health Centers
DUNS: 079674019
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone
PRODUCT DETAILS
NDC Product Code76413-160
Application NumberANDA085025
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateDecember 22, 2016
Generic NameHydrocortisone
INGREDIENTS (8)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCORTISONEActive
Quantity: 25 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT