Carbaglu
These highlights do not include all the information needed to use CARBAGLU safely and effectively. See full prescribing information for CARBAGLU. Carbaglu (carglumic acid) tablets for oral suspensionInitial U.S. Approval: 2010
Approved
Approval ID
10175e73-5172-4dde-a508-8a88b7afc0a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
Recordati Rare Diseases
DUNS: 767598352
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carglumic Acid
PRODUCT DETAILS
NDC Product Code52276-312
Application NumberNDA022562
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 25, 2024
Generic NameCarglumic Acid
INGREDIENTS (7)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
CARGLUMIC ACIDActive
Quantity: 200 mg in 1 1
Code: 5L0HB4V1EW
Classification: ACTIB