FDA.reportPublic FDA data

Constulose

Product NDC
45963-439
11-digit product format
459630439
Labeler code
45963
Product ID
45963-439_7fd63ff0-fccd-408a-9c56-2c2fefdb74fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA090503
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
Constulose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACTULOSE10 g/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9U7D5QH5AE
Rxcui391937, 544452

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
45963-439-63Constulose237 mL in 1 BOTTLESOLUTION2376
45963-439-65Constulose946 mL in 1 BOTTLESOLUTION9466

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-439-63ML - Milliliter45963-43980569c45-a54f-4fd4-905a-b7fe7c589bec12012-07-24
45963-439-65ML - Milliliter45963-4399bccae62-a628-4fe5-b5f0-e554c61aaa0d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LACTULOSEACTIVE INGREDIENT9U7D5QH5AECONSTULOSE (LACTULOSE) SOLUTION [ACTAVIS INC.]2
LACTULOSEACTIVE MOIETY9U7D5QH5AECONSTULOSE (LACTULOSE) SOLUTION [ACTAVIS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-439CONSTULOSE (LACTULOSE) SOLUTION [ACTAVIS PHARMA, INC.]6Current NDC, Legacy NDC, 2 package rows20221013_461ec39f-eeb4-4460-9b5c-62367d47162b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
544452Constulose 10 GM in 15 mL Oral SolutionPSN461ec39f-eeb4-4460-9b5c-62367d47162b6
391937lactulose 10 GM in 15 mL Oral SolutionPSN461ec39f-eeb4-4460-9b5c-62367d47162b6
544452lactulose 667 MG/ML Oral Solution [Constulose]SBD461ec39f-eeb4-4460-9b5c-62367d47162b6
391937lactulose 667 MG/ML Oral SolutionSCD461ec39f-eeb4-4460-9b5c-62367d47162b6
544452Constulose 10 GM per 15 ML SyrupSY461ec39f-eeb4-4460-9b5c-62367d47162b6
544452Constulose 667 MG/ML Oral SolutionSY461ec39f-eeb4-4460-9b5c-62367d47162b6
391937lactulose 10 GM per 15 ML Oral SolutionSY461ec39f-eeb4-4460-9b5c-62367d47162b6
391937lactulose 20 GM per 30 ML Oral SolutionSY461ec39f-eeb4-4460-9b5c-62367d47162b6
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
45963-439-6345963043963237 mL in 1 BOTTLE (45963-439-63) 237 ml2011-02-280000-00-00NoNoCurrent
45963-439-6545963043965946 mL in 1 BOTTLE (45963-439-65) 946 ml2011-02-280000-00-00NoNoCurrent