Lactulose Solution
Lactulose Solution USP, 10 g/15 mL Rising Pharmaceuticals, Inc.
Approved
Approval ID
e75c335b-f19e-42e2-a24f-d891a52d3d34
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2023
Manufacturers
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lactulose Solution USP, 10 g/15 mL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-592
Application NumberANDA076645
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lactulose Solution USP, 10 g/15 mL
Product Specifications
Route of AdministrationORAL, RECTAL
Effective DateMay 24, 2023
FDA Product Classification
INGREDIENTS (4)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTULOSEActive
Quantity: 10 g in 15 mL
Code: 9U7D5QH5AE
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT