FDA.reportPublic FDA data

KRISTALOSE

Product NDC
66220-719
11-digit product format
662200719
Labeler code
66220
Product ID
66220-719_85528d56-e38f-4565-9136-c7639b479634
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lactulose
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Cumberland Pharmaceuticals Inc.
Application
ANDA074712
Marketing category
ANDA
Marketing start
2012-01-20
Substance
LACTULOSE
Active strength
10 g/10g
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
KRISTALOSE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACTULOSE10 g/10g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9U7D5QH5AE
Rxcui1251190, 1251192, 1251194, 1251196

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
66220-719-302022-09-26C16284748780-1e4f33bdf-9f2d-d8a0-e053-dadaa90a6e4eKRISTALOSE ® (lactulose) For Oral Solution Cumberland Pharmaceuticals Inc.
66220-719-302022-07-29C16284748780-1e4f33bdf-9f2d-d8a0-e053-dadaa90a6e4eKRISTALOSE ® (lactulose) For Oral Solution Cumberland Pharmaceuticals Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66220-719-01KRISTALOSE10 g in 1 POUCHPOWDER, FOR SOLUTION104
66220-719-30KRISTALOSE30 in 1 CARTONPOWDER, FOR SOLUTION304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66220-719-01EA - Each66220-7195ba3d81d-9f5e-4431-ac97-2904210805da12013-08-02
66220-719-30EA - Each66220-719b760842d-4be8-4ad0-a201-ae8232e8bcba12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lactuloseACTIVE INGREDIENT9U7D5QH5AEKRISTALOSE (LACTULOSE) POWDER, FOR SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]1
lactuloseACTIVE MOIETY9U7D5QH5AEKRISTALOSE (LACTULOSE) POWDER, FOR SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66220-719KRISTALOSE (LACTULOSE) POWDER, FOR SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20220927_535dd1ea-b567-49f7-9a84-8ea91e78c466.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251192Kristalose 10 GM Powder for Oral SolutionPSN535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251196Kristalose 20 GM Powder for Oral SolutionPSN535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251190lactulose 10 GM Powder for Oral SolutionPSN535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251194lactulose 20 GM Powder for Oral SolutionPSN535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251192lactulose 10000 MG Powder for Oral Solution [Kristalose]SBD535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251196lactulose 20000 MG Powder for Oral Solution [Kristalose]SBD535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251190lactulose 10000 MG Powder for Oral SolutionSCD535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251194lactulose 20000 MG Powder for Oral SolutionSCD535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251192Kristalose 10 GM Granules for Oral SolutionSY535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251192Kristalose 10 GM Powder for Oral SolutionSY535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251192Kristalose 10000 MG Powder for Oral SolutionSY535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251196Kristalose 20 GM Granules for Oral SolutionSY535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251196Kristalose 20 GM Powder for Oral SolutionSY535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251196Kristalose 20000 MG Powder for Oral SolutionSY535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251190lactulose 10 GM Granules for Oral SolutionSY535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251190lactulose 10 GM Powder for Oral SolutionSY535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251194lactulose 20 GM Granules for Oral SolutionSY535dd1ea-b567-49f7-9a84-8ea91e78c4664
1251194lactulose 20 GM Powder for Oral SolutionSY535dd1ea-b567-49f7-9a84-8ea91e78c4664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66220-719-016622007190110 g in 1 POUCH10 gHistorical
66220-719-306622007193030 POUCH in 1 CARTON (66220-719-30) / 10 g in 1 POUCH (66220-719-01) 30 pouch2012-01-200000-00-00NoNoCurrent