FDA.reportPublic FDA data

LACTULOSE

Product NDC
0121-1154
11-digit product format
001211154
Labeler code
0121
Product ID
0121-1154_6843c997-c52c-4978-b087-647f7c3fa782
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
1966-07-30
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
0121-1154-00LACTULOSE10 in 1 TRAYSOLUTION1022
0121-1154-00LACTULOSE10 in 1 CASESOLUTION1022
0121-1154-06LACTULOSE16 in 1 CARTONSOLUTION1622
0121-1154-06LACTULOSE6 in 1 CASESOLUTION622
0121-1154-30LACTULOSE30 mL in 1 CUP, UNIT-DOSESOLUTION3022
0121-1154-40LACTULOSE10 in 1 TRAYSOLUTION1022
0121-1154-40LACTULOSE4 in 1 CASESOLUTION422

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1154-00ML - Milliliter0121-1154048616b3-cc00-4d98-a96b-e08fc525c21b12017-03-06
0121-1154-06ML - Milliliter0121-1154012bc1b8-8bdc-41cd-9d45-8b881296f2e012020-01-03
0121-1154-30ML - Milliliter0121-1154ad2c10aa-1719-4eb4-a46f-35781c048d8412017-03-06
0121-1154-40ML - Milliliter0121-1154463d590c-96e2-485d-a545-96f9b6317d8e12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LACTULOSEACTIVE INGREDIENT9U7D5QH5AELACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]4
LACTULOSEACTIVE MOIETY9U7D5QH5AELACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]4
WATERINACTIVE INGREDIENT059QF0KO0RLACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1154LACTULOSE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]21Current NDC, Legacy NDC, 7 package rows20241114_0f19e4ed-c90a-4330-a7fa-bf911aa98f09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSN0f19e4ed-c90a-4330-a7fa-bf911aa98f0922
391937lactulose 667 MG/ML Oral SolutionSCD0f19e4ed-c90a-4330-a7fa-bf911aa98f0922
391937lactulose 10 GM per 15 ML Oral SolutionSY0f19e4ed-c90a-4330-a7fa-bf911aa98f0922
391937lactulose 20 GM per 30 ML Oral SolutionSY0f19e4ed-c90a-4330-a7fa-bf911aa98f0922
391937lactulose 10 GM in 15 mL Oral SolutionPSN3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd711
391937lactulose 667 MG/ML Oral SolutionSCD3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd711
391937lactulose 10 GM per 15 ML Oral SolutionSY3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd711
391937lactulose 20 GM per 30 ML Oral SolutionSY3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1154-000012111540010 TRAY in 1 CASE (0121-1154-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1154-30) 10 tray2019-05-030000-00-00NoNoCurrent
0121-1154-06001211154066 CARTON in 1 CASE (0121-1154-06) > 16 CUP, UNIT-DOSE in 1 CARTON > 30 mL in 1 CUP, UNIT-DOSE6 carton2019-05-030000-00-00NoNoCurrent
0121-1154-300012111543030 mL in 1 CUP, UNIT-DOSE30 mlHistorical
0121-1154-40001211154404 TRAY in 1 CASE (0121-1154-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1154-30) 4 tray2019-05-03NoNoCurrent
0121-1154-50001211154505 CASE in 1 CASE (0121-1154-50) > 10 CASE in 1 CASE (0121-1154-00) > 4 TRAY in 1 CASE (0121-1154-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE (0121-1154-30) 5 case2022-11-190000-00-00NoNoCurrent