Hydrocortisone
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%
Approved
Approval ID
3347f4b4-7ccc-48c8-bc95-4435f2b08253
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5834
Application NumberANDA081203
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 5, 2011
FDA Product Classification
INGREDIENTS (3)
HYDROCORTISONEActive
Quantity: 25 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT