18 companies list lactulose as a human prescription drug in the openFDA NDC Directory, led by PAI Holdings, LLC, Chartwell RX, LLC., APOZEAL PHARMACEUTICALS INC, Actavis LLC, Foxland Pharmaceuticals, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.

Is there a generic lactulose?

18 companies list lactulose under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.

Who supplies lactulose active ingredient?

6 companies list lactulose as a bulk ingredient, including Lacsa Pty Ltd., Danipharm A/S, Fresenius Kabi AUT GmbH, Fresenius Kabi Austria GmbH.

Drug

Who makes lactulose?

18 companies list lactulose as a human prescription drug, including under the names Constulose, Enulose, Generlac, KRISTALOSE. Forms: powder, for solution; solution. Routes: oral, rectal.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing lactulose

Company	Forms	Application	NDCs	Registered sites
PAI Holdings, LLCUnited States	powder, for solution; solution	ANDAANDA074623, ANDA217914	6	1
Chartwell RX, LLC.	solution	ANDAANDA074603, ANDA209517	4	0
APOZEAL PHARMACEUTICALS INCUnited States	solution	ANDAANDA203762, ANDA207786	2	1
Actavis LLCUnited States	solution	ANDAANDA090502, ANDA090503	2	1
Foxland Pharmaceuticals, LLCUnited States	solution	ANDAANDA074712	2	1
Trifluent Pharma LLCUnited States	powder, for solution	ANDAANDA217914	2	1
Chartwell Governmental & Specialty RX, LLC.	solution	ANDAANDA209517	2	0
Cumberland Assured Products Inc.	powder, for solution	ANDAANDA074712	2	0
Cumberland Pharmaceuticals Inc.	powder, for solution	ANDAANDA074712	2	0
Cardinal Health 418, Inc.United States	solution	ANDAANDA074623	1	34
Sun Pharmaceutical Industries LimitedIndia	solution	ANDAANDA218858	1	13
Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States	solution	ANDAANDA090503	1	5
Fresenius Kabi Austria GmbHAustria	solution	ANDAANDA090502	1	2
Xttrium Laboratories, Inc.United States	solution	ANDAANDA075911	1	2
Bryant Ranch PrepackUnited States	solution	ANDAANDA090502	1	1
Lannett Company, LLCUnited States	solution	ANDAANDA075993	1	1
Proficient Rx LPUnited States	solution	ANDAANDA074623	1	1
South Atlantic Corporation LLCUnited States	solution	ANDAANDA074623	1	1

Bulk ingredient listings

Lacsa Pty Ltd. · 3 NDC
Danipharm A/SDenmark · 1 NDC
Fresenius Kabi AUT GmbH · 1 NDC
Fresenius Kabi Austria GmbHAustria · 1 NDC
Laboratoires Abbott CIECanada · 1 NDC
Sionc Pharmaceuticals Private LimitedIndia · 1 NDC

Enquiry

Common questions

Who makes lactulose?: 18 companies list lactulose as a human prescription drug in the openFDA NDC Directory, led by PAI Holdings, LLC, Chartwell RX, LLC., APOZEAL PHARMACEUTICALS INC, Actavis LLC, Foxland Pharmaceuticals, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic lactulose?: 18 companies list lactulose under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies lactulose active ingredient?: 6 companies list lactulose as a bulk ingredient, including Lacsa Pty Ltd., Danipharm A/S, Fresenius Kabi AUT GmbH, Fresenius Kabi Austria GmbH.