Lactulose
LACTULOSE For Oral Solution
Approved
Approval ID
3363bdbd-f0d1-45b3-8193-7fdb0a310cc2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Foxland Pharmaceuticals, Inc.
DUNS: 079407828
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lactulose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69067-020
Application NumberANDA074712
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lactulose
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2025
FDA Product Classification
INGREDIENTS (1)
LACTULOSEActive
Quantity: 20 g in 20 g
Code: 9U7D5QH5AE
Classification: ACTIB
Lactulose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69067-010
Application NumberANDA074712
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lactulose
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (1)
LACTULOSEActive
Quantity: 10 g in 10 g
Code: 9U7D5QH5AE
Classification: ACTIB