Lactulose

Product NDC
53217-009
11-digit product format
532170009
Labeler code
53217
Product ID
53217-009_9be2d0a1-1415-47de-87f0-03a66680c62f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA074076
Marketing category
ANDA
Marketing start
1995-07-03
Marketing end
0000-00-00
Substance
LACTULOSE
Active strength
10 g/15mL
Pharmacologic classes
Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
53217-009-012020-01-31C16284748780-19d75b9d0-cd75-f424-e053-dadaa90a57ceLACTULOSE SOLUTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-009-01Lactulose946 mL in 1 BOTTLE, PLASTICSOLUTION9461

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-009-01ML - Milliliter53217-009c96f29ce-5cd1-4e10-b23b-f2493e83dc7012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LACTULOSEACTIVE INGREDIENT9U7D5QH5AELACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
LACTULOSEACTIVE MOIETY9U7D5QH5AELACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
GALACTOSEINACTIVE INGREDIENTX2RN3Q8DNELACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RLACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-009LACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140214_a5a5747b-5194-43a9-8307-f1e05c6eacb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSNa5a5747b-5194-43a9-8307-f1e05c6eacb41
391937lactulose 667 MG/ML Oral SolutionSCDa5a5747b-5194-43a9-8307-f1e05c6eacb41
391937lactulose 10 GM per 15 ML Oral SolutionSYa5a5747b-5194-43a9-8307-f1e05c6eacb41
391937lactulose 20 GM per 30 ML Oral SolutionSYa5a5747b-5194-43a9-8307-f1e05c6eacb41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-009-0153217000901946 mL in 1 BOTTLE, PLASTIC946 mlHistorical