Anusol
Anusol-HC 2.5% (hydrocortisone cream, USP)
Approved
Approval ID
5a0439c8-50a0-4f85-9cb4-9e3a5b0c31e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2023
Manufacturers
FDA
Salix Pharmaceuticals, Inc
DUNS: 793108036
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 Code65649-401
Application NumberANDA088250
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (12)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCORTISONEActive
Quantity: 25 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT