FDA.reportPublic FDA data

Enulose

Product NDC
45963-438
11-digit product format
459630438
Labeler code
45963
Product ID
45963-438_bda4ccaa-fa33-4911-b3bd-12391c365f47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL; RECTAL
Labeler
Actavis Pharma, Inc.
Application
ANDA090502
Marketing category
ANDA
Marketing start
2011-02-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Enulose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACTULOSE10 g/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9U7D5QH5AE
Rxcui391937, 755470

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
45963-438-64Enulose473 mL in 1 BOTTLESOLUTION4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-438-64ML - Milliliter45963-4380ad41bc6-31c0-4948-9ebe-ec576384364812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LACTULOSEACTIVE INGREDIENT9U7D5QH5AEENULOSE (LACTULOSE) SOLUTION [ACTAVIS INC.]2
LACTULOSEACTIVE MOIETY9U7D5QH5AEENULOSE (LACTULOSE) SOLUTION [ACTAVIS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-438ENULOSE (LACTULOSE) SOLUTION [ACTAVIS PHARMA, INC.]8Current NDC, Legacy NDC, 1 package rows20221013_00c42c5c-d19e-4130-aa08-a8bbd47d3e5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
755470Enulose 10 GM in 15 mL Oral SolutionPSNfa3aae7c-6f98-4fbb-85dc-32affe9874d5103
391937lactulose 10 GM in 15 mL Oral SolutionPSNfa3aae7c-6f98-4fbb-85dc-32affe9874d5103
755470lactulose 667 MG/ML Oral Solution [Enulose]SBDfa3aae7c-6f98-4fbb-85dc-32affe9874d5103
391937lactulose 667 MG/ML Oral SolutionSCDfa3aae7c-6f98-4fbb-85dc-32affe9874d5103
755470Enulose 10 GM per 15 ML SyrupSYfa3aae7c-6f98-4fbb-85dc-32affe9874d5103
755470Enulose 667 MG/ML Oral SolutionSYfa3aae7c-6f98-4fbb-85dc-32affe9874d5103
391937lactulose 10 GM per 15 ML Oral SolutionSYfa3aae7c-6f98-4fbb-85dc-32affe9874d5103
391937lactulose 20 GM per 30 ML Oral SolutionSYfa3aae7c-6f98-4fbb-85dc-32affe9874d5103
755470Enulose 10 GM in 15 mL Oral SolutionPSN00c42c5c-d19e-4130-aa08-a8bbd47d3e5b8
391937lactulose 10 GM in 15 mL Oral SolutionPSN00c42c5c-d19e-4130-aa08-a8bbd47d3e5b8
755470lactulose 667 MG/ML Oral Solution [Enulose]SBD00c42c5c-d19e-4130-aa08-a8bbd47d3e5b8
391937lactulose 667 MG/ML Oral SolutionSCD00c42c5c-d19e-4130-aa08-a8bbd47d3e5b8
755470Enulose 10 GM per 15 ML SyrupSY00c42c5c-d19e-4130-aa08-a8bbd47d3e5b8
755470Enulose 667 MG/ML Oral SolutionSY00c42c5c-d19e-4130-aa08-a8bbd47d3e5b8
391937lactulose 10 GM per 15 ML Oral SolutionSY00c42c5c-d19e-4130-aa08-a8bbd47d3e5b8
391937lactulose 20 GM per 30 ML Oral SolutionSY00c42c5c-d19e-4130-aa08-a8bbd47d3e5b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45963-438-6445963043864473 mL in 1 BOTTLE (45963-438-64) 473 ml2011-02-280000-00-00NoNoCurrent