NDC 0116-4005

Lactulose

Lactulose

Lactulose is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Xttrium Laboratories, Inc.. The primary component is Lactulose.

Product ID0116-4005_df62ad54-5abb-4d05-e053-2a95a90aa48d
NDC0116-4005
Product TypeHuman Prescription Drug
Proprietary NameLactulose
Generic NameLactulose
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2022-07-01
Marketing CategoryANDA /
Application NumberANDA075911
Labeler NameXttrium Laboratories, Inc.
Substance NameLACTULOSE
Active Ingredient Strength10 g/15mL
Pharm ClassesAcidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0116-4005-08

237 mL in 1 BOTTLE (0116-4005-08)
Marketing Start Date2022-07-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Lactulose" or generic name "Lactulose"

NDCBrand NameGeneric Name
0116-4005LactuloseLactulose
0121-0577LACTULOSELACTULOSE
0121-0873LACTULOSELactulose
0121-1154LACTULOSELACTULOSE
0121-1746LACTULOSELACTULOSE
0121-4577LACTULOSELACTULOSE
0527-5120LACTULOSELACTULOSE
0527-5125LACTULOSELACTULOSE
0603-1378Lactuloselactulose
13668-574LactuloseLactulose
13668-580LactuloseLactulose
68071-1562LACTULOSELACTULOSE
69067-010LactuloseLactulose
17856-1378LactuloseLactulose
18124-001LactuloseLactulose
18124-002LactuloseLactulose
21695-997LactuloseLactulose
35356-754LactuloseLactulose
50090-0679LactuloseLactulose
50090-3381LactuloseLactulose
50436-3101LactuloseLactulose
50383-795LactuloseLactulose
50383-779LactuloseLactulose
53217-009LactuloseLactulose
55154-5775LACTULOSELACTULOSE
55154-9448LACTULOSELACTULOSE
59741-249LactuloseLactulose
60432-037LactuloseLactulose
66689-039LACTULOSELACTULOSE
66689-038LACTULOSELACTULOSE
49999-800LactuloseLactulose
62135-003LactuloseLactulose
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