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
NDC Product Code65649-401
Application NumberANDA088250
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateJune 1, 2023
Generic Namehydrocortisone
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