LACTULOSE
10 g/15 mL
Approved
Approval ID
6619b25c-26b7-4c43-8c4f-9d33a23c61ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2020
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 002277481
Products 1
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 Code0527-5125
Application NumberANDA075993
Product Classification
M
Marketing Category
C73584
G
Generic Name
LACTULOSE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2020
FDA Product Classification
INGREDIENTS (5)
LACTULOSEActive
Quantity: 10 g in 15 mL
Code: 9U7D5QH5AE
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT