Lactulose Solution by TriRx Huntsville Pharmaceutical Services, LLC Lactulose Solution USP

Lactulose Solution by

Drug Labeling and Warnings

Lactulose Solution by is a Prescription medication manufactured, distributed, or labeled by TriRx Huntsville Pharmaceutical Services, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LACTULOSE SOLUTION- lactulose solution solution 
TriRx Huntsville Pharmaceutical Services, LLC

----------

Lactulose Solution USP

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Warnings

Precautions

To report Suspected adverse reactions, contact Lannett Company, Inc at 1-844-834-0530

Adverse Reactions

Overdosage

Dosage and Administration

How Supplied

Lactulose Display Label

LACTULOSE SOLUTION 
lactulose solution solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 80432-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE) LACTULOSE10 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80432-001-35946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07599301/01/2020
Labeler - TriRx Huntsville Pharmaceutical Services, LLC (117090286)
Establishment
NameAddressID/FEIBusiness Operations
TriRx Huntsville Pharmaceutical Services, LLC117090286manufacture(80432-001)

Revised: 1/2023
Document Id: f1f0ab04-0097-9db4-e053-2995a90aa04c
Set id: b8b710c0-d0ee-3d21-e053-2a95a90ae88f
Version: 2
Effective Time: 20230110
 
TriRx
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.