HYDROCORTISONE VALERATE
HYDROCORTISONE VALERATE
Approved
Approval ID
f165db21-1f03-4f33-8383-196f6adda6e3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2020
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
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 Code61919-010
Application NumberANDA075666
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCORTISONE VALERATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 20, 2020
FDA Product Classification
INGREDIENTS (9)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
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