LACTULOSE
LACTULOSE SOLUTION, USP
Approved
Approval ID
7016bd71-c667-46fc-8c56-5023682e8bbe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2020
Manufacturers
FDA
VistaPharm, Inc.
DUNS: 116743084
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 Code66689-039
Application NumberANDA074138
Product Classification
M
Marketing Category
C73584
G
Generic Name
LACTULOSE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2020
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LACTULOSEActive
Quantity: 10 g in 15 mL
Code: 9U7D5QH5AE
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTULOSE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66689-038
Application NumberANDA074138
Product Classification
M
Marketing Category
C73584
G
Generic Name
LACTULOSE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2020
FDA Product Classification
INGREDIENTS (4)
LACTULOSEActive
Quantity: 20 g in 30 mL
Code: 9U7D5QH5AE
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT