FDA.reportPublic FDA data

Lactulose

Product NDC
50383-795
Requested package NDC
50383-795-16
11-digit product format
503830795
Labeler code
50383
Product ID
50383-795_e004117b-667e-4761-a11c-dea9c84785a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL; RECTAL
Labeler
Akorn
Application
ANDA074077
Marketing category
ANDA
Marketing start
1995-07-03
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50383-79550383-795-16IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074077-001LACTULOSELACTULOSE10GM/15MLSOLUTION / ORAL, RECTAL1995-07-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074077-001LACTULOSE10GM/15MLSOLUTION / ORAL, RECTAL1995-07-03a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-795-162024-01-30C16284748780-11030e365-5525-111a-e063-dadaa90a10e2LACTULOSE SOLUTION, USP
50383-795-642024-01-30C16284748780-11030e365-5525-111a-e063-dadaa90a10e2LACTULOSE SOLUTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-795-16Lactulose473 mL in 1 BOTTLESOLUTION4737
50383-795-64Lactulose1893 mL in 1 BOTTLESOLUTION18937

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-795-16ML - Milliliter50383-795a4b2d779-297e-4cae-b8c1-7d30da01755512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LACTULOSEACTIVE INGREDIENT9U7D5QH5AELACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]2
LACTULOSEACTIVE MOIETY9U7D5QH5AELACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]2
GALACTOSEINACTIVE INGREDIENTX2RN3Q8DNELACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RLACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-795LACTULOSE SOLUTION [AKORN]7Legacy NDC, 2 package rows20220916_ff6b4568-1383-46b6-a1c6-385fc31fb210.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSNff6b4568-1383-46b6-a1c6-385fc31fb2107
391937lactulose 667 MG/ML Oral SolutionSCDff6b4568-1383-46b6-a1c6-385fc31fb2107
391937lactulose 10 GM per 15 ML Oral SolutionSYff6b4568-1383-46b6-a1c6-385fc31fb2107
391937lactulose 20 GM per 30 ML Oral SolutionSYff6b4568-1383-46b6-a1c6-385fc31fb2107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-795-1650383079516473 mL in 1 BOTTLE (50383-795-16) 473 ml1995-07-030000-00-00NoNoCurrent