FDA.reportPublic FDA data

LACTULOSE

Product NDC
0527-5125
11-digit product format
005275125
Labeler code
0527
Product ID
0527-5125_1b869904-b3c5-4f81-a333-1f26b6b2c7bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACTULOSE
Dosage form
SOLUTION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA075993
Marketing category
ANDA
Marketing start
2001-07-26
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
0527-5125-68LACTULOSE237 mL in 1 BOTTLESOLUTION23710
0527-5125-70LACTULOSE473 mL in 1 BOTTLESOLUTION47310
0527-5125-78LACTULOSE946 mL in 1 BOTTLESOLUTION94610
0527-5125-82LACTULOSE1892 mL in 1 BOTTLESOLUTION189210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-5125-70ML - Milliliter0527-5125e7f06ad7-f495-4453-8c22-91a67077959f12020-04-20
0527-5125-78ML - Milliliter0527-5125044bef85-d8be-4560-94a9-f38851df9cbe12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-5125LACTULOSE SOLUTION [LANNETT COMPANY, INC.]10Current NDC, Legacy NDC, 4 package rows20210714_6619b25c-26b7-4c43-8c4f-9d33a23c61ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSN6619b25c-26b7-4c43-8c4f-9d33a23c61ca10
391937lactulose 667 MG/ML Oral SolutionSCD6619b25c-26b7-4c43-8c4f-9d33a23c61ca10
391937lactulose 10 GM per 15 ML Oral SolutionSY6619b25c-26b7-4c43-8c4f-9d33a23c61ca10
391937lactulose 20 GM per 30 ML Oral SolutionSY6619b25c-26b7-4c43-8c4f-9d33a23c61ca10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-5125-6800527512568237 mL in 1 BOTTLE (0527-5125-68) 237 ml2001-07-260000-00-00NoNoCurrent
0527-5125-7000527512570473 mL in 1 BOTTLE (0527-5125-70) 473 ml2001-07-260000-00-00NoNoCurrent
0527-5125-7800527512578946 mL in 1 BOTTLE (0527-5125-78) 946 ml2001-07-260000-00-00NoNoCurrent
0527-5125-82005275125821892 mL in 1 BOTTLE (0527-5125-82) 1892 ml2001-07-260000-00-00NoNoCurrent