Ultravate
These highlights do not include all the information needed to use ULTRAVATE® lotion safely and effectively. See full prescribing information for ULTRAVATE lotion. ULTRAVATE (halobetasol propionate) lotion, for topical useInitial U.S. Approval: 1990
Approved
Approval ID
0d563d44-17fd-4976-9f2c-f1d509f29587
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 2, 2020
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
halobetasol propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10631-122
Application NumberNDA208183
Product Classification
M
Marketing Category
C73594
G
Generic Name
halobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 2, 2020
FDA Product Classification
INGREDIENTS (14)
HALOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 91A0K1TY3Z
Classification: ACTIB
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
DIISOPROPYL ADIPATEInactive
Code: P7E6YFV72X
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT