FDA.reportPublic FDA data

Lactulose

Product NDC
62135-004
11-digit product format
621350004
Labeler code
62135
Product ID
62135-004_49798265-6d70-8bc1-e063-6394a90a59d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA209517
Marketing category
ANDA
Marketing start
2018-11-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lactulose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACTULOSE10 g/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9U7D5QH5AE
Rxcui391937

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-004-24Lactulose10 in 1 TRAYSOLUTION105
62135-004-24Lactulose2 in 1 BOXSOLUTION25
62135-004-43Lactulose30 mL in 1 CUP, UNIT-DOSESOLUTION305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-004-24ML - Milliliter62135-00424c7b3d3-c7d9-40d2-89d4-8412c6923d2112024-08-12
62135-004-43ML - Milliliter62135-0044fde3277-816b-402c-8058-45b4442da92812024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-004LACTULOSE SOLUTION [CHARTWELL RX, LLC]3Current NDC, 3 package rows20240601_d6975cd8-80e0-43e2-809a-175ea7e40715.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSNd6975cd8-80e0-43e2-809a-175ea7e407155
391937lactulose 667 MG/ML Oral SolutionSCDd6975cd8-80e0-43e2-809a-175ea7e407155
391937lactulose 10 GM per 15 ML Oral SolutionSYd6975cd8-80e0-43e2-809a-175ea7e407155
391937lactulose 20 GM per 30 ML Oral SolutionSYd6975cd8-80e0-43e2-809a-175ea7e407155

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-004-24621350004242 TRAY in 1 BOX (62135-004-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (62135-004-43) 2 tray2024-03-19NoNoHistorical
62135-004-436213500044330 mL in 1 CUP, UNIT-DOSE30 mlHistorical