Lactulose

Product NDC
73352-900
11-digit product format
733520900
Labeler code
73352
Product ID
73352-900_3eaf2342-fb58-e0a5-e063-6394a90a7271
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Trifluent Pharma, Inc.
Application
ANDA217914
Marketing category
ANDA
Marketing start
2025-09-13
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
73352-900-01Lactulose10 g in 1 POUCHPOWDER, FOR SOLUTION101
73352-900-15Lactulose15 in 1 CARTONPOWDER, FOR SOLUTION151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-900-01EA - Each73352-900cb17222a-465d-4265-be53-5d8454c625f412025-10-14
73352-900-15EA - Each73352-900bc21dab0-efee-4fb3-8f8f-5b15e052d44a12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251190lactulose 10 GM Powder for Oral SolutionPSN3eaf273a-b49d-2595-e063-6394a90a1cf61
1251194lactulose 20 GM Powder for Oral SolutionPSN3eaf273a-b49d-2595-e063-6394a90a1cf61
1251190lactulose 10000 MG Powder for Oral SolutionSCD3eaf273a-b49d-2595-e063-6394a90a1cf61
1251194lactulose 20000 MG Powder for Oral SolutionSCD3eaf273a-b49d-2595-e063-6394a90a1cf61
1251190lactulose 10 GM Granules for Oral SolutionSY3eaf273a-b49d-2595-e063-6394a90a1cf61
1251190lactulose 10 GM Powder for Oral SolutionSY3eaf273a-b49d-2595-e063-6394a90a1cf61
1251194lactulose 20 GM Granules for Oral SolutionSY3eaf273a-b49d-2595-e063-6394a90a1cf61
1251194lactulose 20 GM Powder for Oral SolutionSY3eaf273a-b49d-2595-e063-6394a90a1cf61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73352-900-017335209000110 g in 1 POUCH10 gHistorical
73352-900-157335209001515 POUCH in 1 CARTON (73352-900-15) / 10 g in 1 POUCH (73352-900-01) 15 pouch2025-09-13NoNoHistorical