LACTULOSE

Product NDC
55154-9448
11-digit product format
551549448
Labeler code
55154
Product ID
55154-9448_c6c822e7-9486-4ad9-81a2-c2b8ee692f32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACTULOSE
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health 107, LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LACTULOSE
Listing expiration
2027-12-31

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
55154-9448-5LACTULOSE30 mL in 1 CUP, UNIT-DOSESOLUTION3010
55154-9448-5LACTULOSE5 in 1 BAGSOLUTION510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-9448-5ML - Milliliter55154-944822651fbe-9ead-4f99-ac57-fee39b11b0eb12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9448LACTULOSE SOLUTION [CARDINAL HEALTH 107, LLC]9Current NDC, Legacy NDC, 2 package rows20250403_3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-9448-5551549448055 CUP, UNIT-DOSE in 1 BAG (55154-9448-5) / 30 mL in 1 CUP, UNIT-DOSE1966-07-302022-01-31NoNoCurrent