Ravicti
These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI (glycerol phenylbutyrate) oral liquid Initial U.S. Approval: 1996
Approved
Approval ID
900e7dc0-9afe-4f50-80de-90567bb78519
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2021
Manufacturers
FDA
Horizon Therapeutics USA, Inc.
DUNS: 033470838
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
glycerol phenylbutyrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75987-050
Application NumberNDA203284
Product Classification
M
Marketing Category
C73594
G
Generic Name
glycerol phenylbutyrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2021
FDA Product Classification
INGREDIENTS (1)
GLYCEROL PHENYLBUTYRATEActive
Quantity: 1.1 g in 1 mL
Code: ZH6F1VCV7B
Classification: ACTIB