Hydrocortisone Valerate
Hydrocortisone Valerate Ointment USP, 0.2%
Approved
Approval ID
1cb06573-1ac8-4dfe-8123-00bbd20a1650
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0560
Application NumberANDA211764
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCORTISONE VALERATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (12)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
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
STEARETH-2Inactive
Code: V56DFE46J5
Classification: IACT
HYDROCORTISONE VALERATEActive
Quantity: 2 mg in 1 g
Code: 68717P8FUZ
Classification: ACTIB