Enulose

(Lactulose Solution USP, 10 g/15 mL)

Approved

Approval ID

fa3aae7c-6f98-4fbb-85dc-32affe9874d5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 15, 2023

Manufacturers

FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code63629-8800

Application NumberANDA090502

Marketing CategoryC73584

Route of AdministrationORAL, RECTAL

Effective DateMarch 31, 2016

Generic NameLactulose

LACTULOSEActive

Quantity: 10 g in 15 mL

Code: 9U7D5QH5AE

Classification: ACTIB

GALACTOSEInactive

Code: X2RN3Q8DNE

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

FRUCTOSEInactive

Code: 6YSS42VSEV

Classification: IACT