FDA.reportPublic FDA data

LACTULOSE

Product NDC
0121-1746
11-digit product format
001211746
Labeler code
0121
Product ID
0121-1746_b73c2ddc-a690-46e1-aa89-40fa890c9ab4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACTULOSE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA074623
Marketing category
ANDA
Marketing start
2019-12-03
Substance
LACTULOSE
Active strength
20 g/30mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
LACTULOSE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACTULOSE20 g/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9U7D5QH5AE
Rxcui391937

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
13620a32-e3b4-4aad-8280-283dce30ddffProduct name120260105
27883b46-af31-44b0-b4ce-e6b4f6d825a7Product name420250812
c1a80c95-0e51-52a0-75fa-75808f51ded8Product name220150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1746-00LACTULOSE10 in 1 CASESOLUTION108
0121-1746-00LACTULOSE10 in 1 TRAYSOLUTION108
0121-1746-06LACTULOSE16 in 1 CARTONSOLUTION168
0121-1746-06LACTULOSE6 in 1 CASESOLUTION68
0121-1746-30LACTULOSE30 mL in 1 CUP, UNIT-DOSESOLUTION308
0121-1746-40LACTULOSE4 in 1 CASESOLUTION48
0121-1746-40LACTULOSE10 in 1 TRAYSOLUTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1746LACTULOSE SOLUTION LACTULOSE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]7Current NDC, Legacy NDC, 7 package rows20240918_cbf0497c-9c8d-4dfa-bebd-64c589468401.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSNcbf0497c-9c8d-4dfa-bebd-64c5894684018
391937lactulose 667 MG/ML Oral SolutionSCDcbf0497c-9c8d-4dfa-bebd-64c5894684018
391937lactulose 10 GM per 15 ML Oral SolutionSYcbf0497c-9c8d-4dfa-bebd-64c5894684018
391937lactulose 20 GM per 30 ML Oral SolutionSYcbf0497c-9c8d-4dfa-bebd-64c5894684018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1746-000012117460010 TRAY in 1 CASE (0121-1746-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30) 10 tray2019-12-030000-00-00NoNoCurrent
0121-1746-06001211746066 CARTON in 1 CASE (0121-1746-06) / 16 CUP, UNIT-DOSE in 1 CARTON / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30) 6 carton2019-12-030000-00-00NoNoCurrent
0121-1746-300012117463030 mL in 1 CUP, UNIT-DOSE30 mlHistorical
0121-1746-40001211746404 TRAY in 1 CASE (0121-1746-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30) 4 tray2019-12-030000-00-00NoNoCurrent