FDA.reportPublic FDA data

Lactulose

Product NDC
0121-1930
11-digit product format
001211930
Labeler code
0121
Product ID
0121-1930_e4873a34-cdc0-4c96-b04f-c84641f52236
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA217914
Marketing category
ANDA
Marketing start
2025-03-17
Substance
LACTULOSE
Active strength
20 g/20g
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/20g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9U7D5QH5AE
Rxcui1251190, 1251194

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
0121-1930-01Lactulose20 g in 1 POUCHPOWDER, FOR SOLUTION203
0121-1930-30Lactulose30 in 1 CARTONPOWDER, FOR SOLUTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1930-01EA - Each0121-193099ec5bc5-f66a-4df0-948c-7936aea11acb12025-05-14
0121-1930-30EA - Each0121-1930c803e871-89b6-4c50-a06a-1c34e9e2a3f012025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1930LACTULOSE POWDER, FOR SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]3Current NDC, 2 package rows20250321_5ae4b6da-44df-419a-9f2b-8c4d79f635c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251190lactulose 10 GM Powder for Oral SolutionPSN5ae4b6da-44df-419a-9f2b-8c4d79f635c83
1251194lactulose 20 GM Powder for Oral SolutionPSN5ae4b6da-44df-419a-9f2b-8c4d79f635c83
1251190lactulose 10000 MG Powder for Oral SolutionSCD5ae4b6da-44df-419a-9f2b-8c4d79f635c83
1251194lactulose 20000 MG Powder for Oral SolutionSCD5ae4b6da-44df-419a-9f2b-8c4d79f635c83
1251190lactulose 10 GM Granules for Oral SolutionSY5ae4b6da-44df-419a-9f2b-8c4d79f635c83
1251190lactulose 10 GM Powder for Oral SolutionSY5ae4b6da-44df-419a-9f2b-8c4d79f635c83
1251194lactulose 20 GM Granules for Oral SolutionSY5ae4b6da-44df-419a-9f2b-8c4d79f635c83
1251194lactulose 20 GM Powder for Oral SolutionSY5ae4b6da-44df-419a-9f2b-8c4d79f635c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-1930-010012119300120 g in 1 POUCH20 gHistorical
0121-1930-300012119303030 POUCH in 1 CARTON (0121-1930-30) / 20 g in 1 POUCH (0121-1930-01) 30 pouch2025-03-17NoNoHistorical