LACTULOSE

Product NDC
82804-107
11-digit product format
828040107
Labeler code
82804
Product ID
82804-107_6bbabdc6-f6a8-4f67-a448-e452d1928deb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074623
Marketing category
ANDA
Marketing start
2019-12-03
Substance
LACTULOSE
Active strength
10 g/15mL
Pharmacologic classes
Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9U7D5QH5AELACTULOSE4618-18-2LACTULOSE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-107-4782804010747473 mL in 1 BOTTLE (82804-107-47) 473 ml2024-06-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Lactulose Solution USP 10 g/15 mLProficient Rx LP2024-06-01HUMAN PRESCRIPTION DRUG LABEL1