HYDROCORTISONE VALERATE
Rx only HYDROCORTISONE VALERATE Cream USP, 0.2%
Approved
Approval ID
fd68f7a2-fa0d-4d56-8e92-71cd955cc7a9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROCORTISONE VALERATE
PRODUCT DETAILS
NDC Product Code0713-0720
Application NumberANDA213724
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateNovember 29, 2023
Generic NameHYDROCORTISONE VALERATE
INGREDIENTS (11)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
STEARETH-2Inactive
Code: V56DFE46J5
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARETH-100Inactive
Code: 4OH5W9UM87
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
HYDROCORTISONE VALERATEActive
Quantity: 2 mg in 1 g
Code: 68717P8FUZ
Classification: ACTIB