FDA.reportPublic FDA data

LACTULOSE

Product NDC
0527-5120
11-digit product format
005275120
Labeler code
0527
Product ID
0527-5120_bfb6944f-ad8c-4bcf-98bf-b0eb806e9172
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACTULOSE
Dosage form
SOLUTION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA074623
Marketing category
ANDA
Marketing start
1996-07-30
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
0527-5120-68LACTULOSE237 mL in 1 BOTTLESOLUTION2373
0527-5120-70LACTULOSE473 mL in 1 BOTTLESOLUTION4733
0527-5120-78LACTULOSE946 mL in 1 BOTTLESOLUTION9463

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-5120-70ML - Milliliter0527-5120c0b6cc23-a374-485c-9904-d1dfb025a97912019-04-11
0527-5120-78ML - Milliliter0527-5120d0429bfe-acc4-4a3a-ab83-77de36ffc38e12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-5120LACTULOSE SOLUTION [LANNETT COMPANY, INC.]3Current NDC, Legacy NDC, 3 package rows20220728_8658d2ee-7708-47d0-bb93-74c1f4e17960.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSN8658d2ee-7708-47d0-bb93-74c1f4e179603
391937lactulose 667 MG/ML Oral SolutionSCD8658d2ee-7708-47d0-bb93-74c1f4e179603
391937lactulose 10 GM per 15 ML Oral SolutionSY8658d2ee-7708-47d0-bb93-74c1f4e179603
391937lactulose 20 GM per 30 ML Oral SolutionSY8658d2ee-7708-47d0-bb93-74c1f4e179603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-5120-6800527512068237 mL in 1 BOTTLE (0527-5120-68) 237 ml1996-07-300000-00-00NoNoCurrent
0527-5120-7000527512070473 mL in 1 BOTTLE (0527-5120-70) 473 ml1996-07-300000-00-00NoNoCurrent
0527-5120-7800527512078946 mL in 1 BOTTLE (0527-5120-78) 946 ml1996-07-300000-00-00NoNoCurrent