Hydrocortisone Valerate
Approved
Approval ID
7b466e08-a51f-414c-bf87-eafed577ff2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 29, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-4451
Application NumberANDA075042
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone Valerate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 29, 2010
FDA Product Classification
INGREDIENTS (11)
HYDROCORTISONE VALERATEActive
Quantity: 2 mg in 1 g
Code: 68717P8FUZ
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARETH-2Inactive
Code: V56DFE46J5
Classification: IACT
STEARETH-100Inactive
Code: 4OH5W9UM87
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
Hydrocortisone Valerate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5251
Application NumberANDA075043
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone Valerate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 29, 2010
FDA Product Classification
INGREDIENTS (12)
HYDROCORTISONE VALERATEActive
Quantity: 2 mg in 1 g
Code: 68717P8FUZ
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE BInactive
Code: HHT01ZNK31
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARETH-100Inactive
Code: 4OH5W9UM87
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARETH-2Inactive
Code: V56DFE46J5
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 10/29/2010
Rx only
For Dermatologic Use Only. Not for Ophthalmic Use.