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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	81033-241		I	Inactivated by FDA	2026-08-10
excluded package	package	81033-241	81033-241-50	I	Inactivated by FDA	2026-08-10
excluded package	package	81033-241	81033-241-51	I	Inactivated by FDA	2026-08-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076645-001	LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA		2003-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076645-001	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	2003-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076645-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL		2003-07-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076645-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076645-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076645-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076645-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076645-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076645-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076645-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076645-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076645-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076645-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076645-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076645-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076645-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076645-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076645-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076645-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076645-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076645-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076645-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076645-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076645-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076645-001	AA	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076645-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lactulose Solution
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9U7D5QH5AE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
391937	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2d90e2a4-334f-ab68-e063-6294a90affa6	Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

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

DailyMed Billing Units#

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

DailyMed Dashboard NDC Coverage#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lactulose Solution	LACTULOSE SOLUTION USP, 10 G/15 ML	Rising Pharma Holdings, Inc.	e75c335b-f19e-42e2-a24f-d891a52d3d34	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076645 application number: ANDA076645
Lactulose Solution	LACTULOSE SOLUTION USP, 10 G/15 ML	Kesin Pharma Corporation	2d90e2a4-334f-ab68-e063-6294a90affa6	2025-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076645 application number: ANDA076645 ndc (product): 81033-241
Lactulose Solution	LACTULOSE SOLUTION USP, 10 G/15 ML	Bajaj Medical, LLC	d460b1a2-9091-2ac9-e053-2995a90aa1d2	2022-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076645 application number: ANDA076645

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

DailyMed RxNorm Mappings#

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

Packages#

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