Lactulose
LACTULOSE SOLUTION, USP
Approved
Approval ID
a5a5747b-5194-43a9-8307-f1e05c6eacb4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 2, 2013
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code53217-009
Application NumberANDA074076
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lactulose
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2013
FDA Product Classification
INGREDIENTS (5)
LACTULOSEActive
Quantity: 10 g in 15 mL
Code: 9U7D5QH5AE
Classification: ACTIB
GALACTOSEInactive
Code: X2RN3Q8DNE
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT