Sodium Phenylbutyrate
Sodium Phenylbutyrate Powder (SO-dee-um fen-ill-BYOU-tih-rate) Rx Only
Approved
Approval ID
e914d451-6122-43f9-af8d-c80ed1cb215d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2022
Manufacturers
FDA
Sigmapharm Laboratories, LLC
DUNS: 556234636
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Phenylbutyrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-086
Application NumberANDA202819
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Phenylbutyrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2022
FDA Product Classification
INGREDIENTS (3)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SODIUM PHENYLBUTYRATEActive
Quantity: 0.94 g in 1 g
Code: NT6K61736T
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT