Lactulose Solution

Product NDC: 81033-241
11-digit product format: 810330241
Labeler code: 81033
Product ID: 81033-241_2d90dbd5-a13b-3875-e063-6394a90a1dc0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lactulose Solution USP, 10 g/15 mL
Dosage form: SOLUTION
Route: ORAL; RECTAL
Labeler: Kesin Pharma Corporation
Application: ANDA076645
Marketing category: ANDA
Marketing start: 2021-04-16
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#

Ingredient, Strength table
Ingredient	Strength
LACTULOSE	10 g/15mL

Field, Values table
Field	Values
Unii	9U7D5QH5AE
Rxcui	391937

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
13620a32-e3b4-4aad-8280-283dce30ddff	Product name	1	20260105
27883b46-af31-44b0-b4ce-e6b4f6d825a7	Product name	4	20250812
c1a80c95-0e51-52a0-75fa-75808f51ded8	Product name	2	20150421

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81033-241-50	2026-01-29	C162847	48780-1	49896155-a75c-586f-e063-e6dba90add90	"These highlights do not include all the information needed to use" "see full prescribing information for" and "Initial U.S. Approval" Lactulose Solution USP, 10 g/15 mL
81033-241-51	2026-01-29	C162847	48780-1	49896155-a75c-586f-e063-e6dba90add90	"These highlights do not include all the information needed to use" "see full prescribing information for" and "Initial U.S. Approval" Lactulose Solution USP, 10 g/15 mL

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81033-241-15	Lactulose Solution	15 mL in 1 CUP, UNIT-DOSE	SOLUTION	15	4
81033-241-30	Lactulose Solution	30 mL in 1 CUP, UNIT-DOSE	SOLUTION	30	4
81033-241-50	Lactulose Solution	100 in 1 CASE	SOLUTION	100	4
81033-241-51	Lactulose Solution	100 in 1 CASE	SOLUTION	100	4
81033-241-32	Lactulose Solution	15 mL in 1 BOTTLE, PLASTIC	SOLUTION	15	1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81033-241-15	ML - Milliliter	81033-241	3f30bd00-0b44-4e43-8c37-e6275e49d724	1	2024-05-16
81033-241-30	ML - Milliliter	81033-241	63a14240-811e-457e-905f-940ecc56739a	1	2024-07-12
81033-241-32	ML - Milliliter	81033-241	b12c6ae7-df5e-47a8-96f6-379008789df3	1	2025-03-04
81033-241-50	ML - Milliliter	81033-241	6a340512-d39f-49ea-9e9b-5f67baca8244	1	2024-05-16
81033-241-51	ML - Milliliter	81033-241	d8018e04-a8d8-404d-88d1-81472cc1f8fa	1	2024-07-12

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81033-241	LACTULOSE SOLUTION (LACTULOSE SOLUTION USP, 10 G/15 ML) SOLUTION [KESIN PHARMA CORPORATION]	4	Current NDC, 4 package rows	20241207_163d5093-e35c-0bbf-e063-6294a90a803e.zip
81033-241	LACTULOSE SOLUTION (LACTULOSE SOLUTION USP, 10 G/15 ML) SOLUTION [KESIN PHARMA CORPORATION]	1	Current NDC, 1 package rows	20250217_2d90e2a4-334f-ab68-e063-6294a90affa6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9U7D5QH5AE	LACTULOSE	4618-18-2	LACTULOSE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
391937	lactulose 10 GM in 15 mL Oral Solution	PSN	163d5093-e35c-0bbf-e063-6294a90a803e	4
391937	lactulose 667 MG/ML Oral Solution	SCD	163d5093-e35c-0bbf-e063-6294a90a803e	4
391937	lactulose 10 GM per 15 ML Oral Solution	SY	163d5093-e35c-0bbf-e063-6294a90a803e	4
391937	lactulose 20 GM per 30 ML Oral Solution	SY	163d5093-e35c-0bbf-e063-6294a90a803e	4
391937	lactulose 10 GM in 15 mL Oral Solution	PSN	2d90e2a4-334f-ab68-e063-6294a90affa6	1
391937	lactulose 667 MG/ML Oral Solution	SCD	2d90e2a4-334f-ab68-e063-6294a90affa6	1
391937	lactulose 10 GM per 15 ML Oral Solution	SY	2d90e2a4-334f-ab68-e063-6294a90affa6	1
391937	lactulose 20 GM per 30 ML Oral Solution	SY	2d90e2a4-334f-ab68-e063-6294a90affa6	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81033-241-15	81033024115	15 mL in 1 CUP, UNIT-DOSE	15 ml				Historical
81033-241-30	81033024130	30 mL in 1 CUP, UNIT-DOSE	30 ml				Historical
81033-241-32	81033024132	15 mL in 1 BOTTLE, PLASTIC (81033-241-32)	15 ml	2025-02-02	No	No	Current
81033-241-50	81033024150	100 in 1 CASE					Historical
81033-241-51	81033024151	100 in 1 CASE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lactulose Solution USP, 10 g/15 mL	Kesin Pharma Corporation	2025-02-02	HUMAN PRESCRIPTION DRUG LABEL	1
Lactulose Solution	Kesin Pharma Corporation	2024-12-03	HUMAN PRESCRIPTION DRUG LABEL	4