FDA.reportPublic FDA data

Lactulose

Product NDC
59741-249
11-digit product format
597410249
Labeler code
59741
Product ID
59741-249_fa6dda90-d429-4afa-b570-fe386ed98eb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL
Labeler
Bio-Pharm, Inc.
Application
ANDA207786
Marketing category
ANDA
Marketing start
2018-06-13
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
59741-249-092020-01-31C16284748780-19d75b9cf-ceff-f424-e053-dadaa90a57ceLactulose Solution, USP
59741-249-172020-01-31C16284748780-19d75b9cf-ceff-f424-e053-dadaa90a57ceLactulose Solution, USP
59741-249-332020-01-31C16284748780-19d75b9cf-ceff-f424-e053-dadaa90a57ceLactulose Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59741-249-09Lactulose237 mL in 1 BOTTLESOLUTION2373
59741-249-17Lactulose473 mL in 1 BOTTLESOLUTION4733
59741-249-33Lactulose946 mL in 1 BOTTLESOLUTION9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59741-249LACTULOSE SOLUTION [BIO-PHARM, INC.]3Legacy NDC, 3 package rows20180619_e9734719-07b9-4ac9-b082-be07f4e9a68f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSNe9734719-07b9-4ac9-b082-be07f4e9a68f3
391937lactulose 667 MG/ML Oral SolutionSCDe9734719-07b9-4ac9-b082-be07f4e9a68f3
391937lactulose 10 GM per 15 ML Oral SolutionSYe9734719-07b9-4ac9-b082-be07f4e9a68f3
391937lactulose 20 GM per 30 ML Oral SolutionSYe9734719-07b9-4ac9-b082-be07f4e9a68f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59741-249-0959741024909237 mL in 1 BOTTLE237 mlHistorical
59741-249-1759741024917473 mL in 1 BOTTLE473 mlHistorical
59741-249-3359741024933946 mL in 1 BOTTLE946 mlHistorical