FDA.reportPublic FDA data

Lactulose

Product NDC
83745-405
11-digit product format
837450405
Labeler code
83745
Product ID
83745-405_b0b2ff56-185f-4e6e-9519-14af29f765e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL
Labeler
APOZEAL PHARMACEUTICALS INC
Application
ANDA207786
Marketing category
ANDA
Marketing start
2024-12-20
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
83745-405-08Lactulose237 mL in 1 BOTTLESOLUTION2373
83745-405-16Lactulose473 mL in 1 BOTTLESOLUTION4733
83745-405-32Lactulose946 mL in 1 BOTTLESOLUTION9463

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83745-405-08ML - Milliliter83745-40557b0c511-46be-44b8-9b00-a3beaafe684412025-02-10
83745-405-16ML - Milliliter83745-40580031205-3983-41dd-b6bd-5e10b853c60812025-02-10
83745-405-32ML - Milliliter83745-405d3fe5056-6dce-4712-aaa4-d2be859e53b712025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83745-405LACTULOSE SOLUTION [APOZEAL PHARMACEUTICALS INC]2Current NDC, 3 package rows20241222_72ac130a-de85-464d-9e9b-05cac0c54db1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
391937lactulose 10 GM in 15 mL Oral SolutionPSN72ac130a-de85-464d-9e9b-05cac0c54db13
391937lactulose 667 MG/ML Oral SolutionSCD72ac130a-de85-464d-9e9b-05cac0c54db13
391937lactulose 10 GM per 15 ML Oral SolutionSY72ac130a-de85-464d-9e9b-05cac0c54db13
391937lactulose 20 GM per 30 ML Oral SolutionSY72ac130a-de85-464d-9e9b-05cac0c54db13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83745-405-0883745040508237 mL in 1 BOTTLE (83745-405-08) 237 ml2024-12-20NoNoHistorical
83745-405-1683745040516473 mL in 1 BOTTLE (83745-405-16) 473 ml2024-12-20NoNoHistorical
83745-405-3283745040532946 mL in 1 BOTTLE (83745-405-32) 946 ml2024-12-20NoNoHistorical