FDA.reportPublic FDA data

Lactulose

Product NDC
21695-997
11-digit product format
216950997
Labeler code
21695
Product ID
21695-997_a61e6ba8-b342-4815-9623-eb0c319ecc74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lactulose
Dosage form
SOLUTION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074623
Marketing category
ANDA
Marketing start
2004-04-19
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
E
Listing certified through
2017-12-31
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
21695-997-322019-09-24C16284748780-1934fe258-47df-48b1-e053-8cdaa90a720aLactulose

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-997-32Lactulose946 mL in 1 BOTTLESOLUTION9461

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-997-32ML - Milliliter21695-997b5883c9f-917f-4308-99cf-2d81884cf3ad12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LACTULOSEACTIVE INGREDIENT9U7D5QH5AELACTULOSE SOLUTION [REBEL DISTRIBUTORS CORP]1
LACTULOSEACTIVE MOIETY9U7D5QH5AELACTULOSE SOLUTION [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LACTULOSE SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILACTULOSE SOLUTION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RLACTULOSE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-997LACTULOSE SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120511_a61e6ba8-b342-4815-9623-eb0c319ecc74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSNa61e6ba8-b342-4815-9623-eb0c319ecc741
391937lactulose 667 MG/ML Oral SolutionSCDa61e6ba8-b342-4815-9623-eb0c319ecc741
391937lactulose 10 GM per 15 ML Oral SolutionSYa61e6ba8-b342-4815-9623-eb0c319ecc741
391937lactulose 20 GM per 30 ML Oral SolutionSYa61e6ba8-b342-4815-9623-eb0c319ecc741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-997-3221695099732946 mL in 1 BOTTLE946 mlHistorical