Constulose

Product NDC
50090-3436
11-digit product format
500903436
Labeler code
50090
Product ID
50090-3436_a0bed20c-bdb6-42a7-84ec-676852a0a352
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090503
Marketing category
ANDA
Marketing start
2011-02-28
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
2022-12-31
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
50090-3436-02023-01-30C16284748780-1f386c64a-0b10-0266-e053-dadaa90a7c1a(Lactulose Solution USP, 10 g/15 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3436-0Constulose237 mL in 1 BOTTLESOLUTION2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3436-0ML - Milliliter50090-343696becf80-530e-46e3-aaf0-1f4db0ee8e3012019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3436CONSTULOSE (LACTULOSE) SOLUTION [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20210303_f34607bc-d4d3-4997-b4fb-1950efbc15ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
544452Constulose 10 GM in 15 mL Oral SolutionPSNf34607bc-d4d3-4997-b4fb-1950efbc15ba4
391937lactulose 10 GM in 15 mL Oral SolutionPSNf34607bc-d4d3-4997-b4fb-1950efbc15ba4
544452lactulose 667 MG/ML Oral Solution [Constulose]SBDf34607bc-d4d3-4997-b4fb-1950efbc15ba4
391937lactulose 667 MG/ML Oral SolutionSCDf34607bc-d4d3-4997-b4fb-1950efbc15ba4
544452Constulose 10 GM per 15 ML SyrupSYf34607bc-d4d3-4997-b4fb-1950efbc15ba4
544452Constulose 667 MG/ML Oral SolutionSYf34607bc-d4d3-4997-b4fb-1950efbc15ba4
391937lactulose 10 GM per 15 ML Oral SolutionSYf34607bc-d4d3-4997-b4fb-1950efbc15ba4
391937lactulose 20 GM per 30 ML Oral SolutionSYf34607bc-d4d3-4997-b4fb-1950efbc15ba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3436-050090343600237 mL in 1 BOTTLE (50090-3436-0) 237 ml2018-04-160000-00-00NoNoCurrent