LACTULOSE

Product NDC
17856-0874
11-digit product format
178560874
Labeler code
17856
Product ID
17856-0874_3fb6eaf7-8029-7a5c-e063-6294a90a6889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corp.
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACTULOSE10 g/15mL

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
17856-0874-3LACTULOSE30 mL in 1 CUP, UNIT-DOSESOLUTION301
17856-0874-3LACTULOSE50 in 1 CASESOLUTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0874-3ML - Milliliter17856-08746835883f-8bcc-43f0-8237-dbfc9b6a7f1612026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSN3fb6e908-893c-5a57-e063-6294a90a1bfc1
391937lactulose 667 MG/ML Oral SolutionSCD3fb6e908-893c-5a57-e063-6294a90a1bfc1
391937lactulose 10 GM per 15 ML Oral SolutionSY3fb6e908-893c-5a57-e063-6294a90a1bfc1
391937lactulose 20 GM per 30 ML Oral SolutionSY3fb6e908-893c-5a57-e063-6294a90a1bfc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
17856-0874-31785608740350 CUP, UNIT-DOSE in 1 CASE (17856-0874-3) / 30 mL in 1 CUP, UNIT-DOSE2025-09-26NoNoHistorical