Lactulose

Product NDC
69067-010
11-digit product format
690670010
Labeler code
69067
Product ID
69067-010_4618824a-2b40-3d54-e063-6394a90a4b96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL
Labeler
Foxland Pharmaceuticals, Inc.
Application
ANDA074712
Marketing category
ANDA
Marketing start
2018-09-21
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
Lactulose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACTULOSE10 g/10g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9U7D5QH5AE
Rxcui1251190, 1251194

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
69067-010-15Lactulose10 g in 1 POUCHSOLUTION109
69067-010-15Lactulose15 in 1 CARTONSOLUTION159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69067-010-15EA - Each69067-010d06f3a3a-0b0f-4bba-acc4-83aedfea8be912018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69067-010LACTULOSE SOLUTION [FOXLAND PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20250426_3363bdbd-f0d1-45b3-8193-7fdb0a310cc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251190lactulose 10 GM Powder for Oral SolutionPSN3363bdbd-f0d1-45b3-8193-7fdb0a310cc29
1251194lactulose 20 GM Powder for Oral SolutionPSN3363bdbd-f0d1-45b3-8193-7fdb0a310cc29
1251190lactulose 10000 MG Powder for Oral SolutionSCD3363bdbd-f0d1-45b3-8193-7fdb0a310cc29
1251194lactulose 20000 MG Powder for Oral SolutionSCD3363bdbd-f0d1-45b3-8193-7fdb0a310cc29
1251190lactulose 10 GM Granules for Oral SolutionSY3363bdbd-f0d1-45b3-8193-7fdb0a310cc29
1251190lactulose 10 GM Powder for Oral SolutionSY3363bdbd-f0d1-45b3-8193-7fdb0a310cc29
1251194lactulose 20 GM Granules for Oral SolutionSY3363bdbd-f0d1-45b3-8193-7fdb0a310cc29
1251194lactulose 20 GM Powder for Oral SolutionSY3363bdbd-f0d1-45b3-8193-7fdb0a310cc29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69067-010-156906700101515 POUCH in 1 CARTON (69067-010-15) / 10 g in 1 POUCH15 pouch2018-09-210000-00-00NoNoCurrent