DEA schedule
Is lactulose a controlled substance?
Federal schedule for lactulose from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Lactulose is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and lactulose is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 37 prescription listings from 22 labelers, none with a DEA schedule |
| DEA controlled substances list | lactulose is not on the list |
Lactulose NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 45963-439 | Constulose | solution | 10 g/15mL | Actavis Pharma, Inc. | None |
| 45963-438 | Enulose | solution | 10 g/15mL | Actavis Pharma, Inc. | None |
| 63629-8800 | Enulose | solution | 10 g/15mL | Bryant Ranch Prepack | None |
| 62135-892 | Generlac | solution | 10 g/15mL | Chartwell RX, LLC | None |
| 66220-719 | KRISTALOSE | powder, for solution | 10 g/10g | Cumberland Pharmaceuticals Inc. | None |
| 66220-729 | KRISTALOSE | powder, for solution | 20 g/20g | Cumberland Pharmaceuticals Inc. | None |
| 0121-0965 | Lactulose | powder, for solution | 10 g/10g | PAI Holdings, LLC dba PAI Pharma | None |
| 73352-900 | Lactulose | powder, for solution | 10 g/10g | Trifluent Pharma, Inc. | None |
| 85592-819 | LACTULOSE Crystalline | powder, for solution | 10 g/10g | Cumberland Assured Products Inc. | None |
| 0121-1930 | Lactulose | powder, for solution | 20 g/20g | PAI Holdings, LLC dba PAI Pharma | None |
| 73352-905 | Lactulose | powder, for solution | 20 g/20g | Trifluent Pharma, Inc. | None |
| 85592-829 | LACTULOSE Crystalline | powder, for solution | 20 g/20g | Cumberland Assured Products Inc. | None |
| 69067-010 | Lactulose | solution | 10 g/10g | Foxland Pharmaceuticals, Inc. | None |
| 0116-4005 | Lactulose | solution | 10 g/15mL | Xttrium Laboratories, Inc. | None |
| 0121-0873 | LACTULOSE | solution | 10 g/15mL | PAI Holdings, LLC dba PAI Pharma | None |
| 0121-4577 | LACTULOSE | solution | 10 g/15mL | PAI Holdings, LLC dba PAI Pharma | None |
| 0527-5125 | LACTULOSE | solution | 10 g/15mL | Lannett Company, Inc. | None |
| 17856-0874 | LACTULOSE | solution | 10 g/15mL | Atlantic Biologicals Corp. | None |
| 18124-002 | Lactulose | solution | 10 g/15mL | Fresenius Kabi Austria GmbH | None |
| 51672-4243 | Lactulose | solution | 10 g/15mL | Sun Pharmaceutical Industries, Inc. | None |
| 60687-917 | Lactulose | solution | 10 g/15mL | American Health Packaging | None |
| 62135-002 | Lactulose | solution | 10 g/15mL | Chartwell RX, LLC | None |
| 62135-003 | Lactulose | solution | 10 g/15mL | Chartwell RX, LLC. | None |
| 62135-004 | Lactulose | solution | 10 g/15mL | Chartwell RX, LLC | None |
| 68999-002 | Lactulose | solution | 10 g/15mL | Chartwell Governmental & Specialty RX, LLC. | None |
| 82804-107 | LACTULOSE | solution | 10 g/15mL | Proficient Rx LP | None |
| 83745-249 | Lactulose | solution | 10 g/15mL | APOZEAL PHARMACEUTICALS INC | None |
| 83745-405 | Lactulose | solution | 10 g/15mL | APOZEAL PHARMACEUTICALS INC | None |
| 69067-020 | Lactulose | solution | 20 g/20g | Foxland Pharmaceuticals, Inc. | None |
| 0121-1154 | LACTULOSE | solution | 20 g/30mL | PAI Holdings, LLC dba PAI Pharma | None |
| 0121-1746 | LACTULOSE | solution | 20 g/30mL | PAI Holdings, LLC dba PAI Pharma | None |
| 55154-9448 | LACTULOSE | solution | 20 g/30mL | Cardinal Health 107, LLC | None |
| 68999-004 | Lactulose | solution | 20 g/30mL | Chartwell Governmental & Specialty RX, LLC. | None |
| 61037-471 | Lactulose Solution | solution | 10 g/15mL | Bajaj Medical, LLC | None |
| 64980-592 | Lactulose Solution | solution | 10 g/15mL | Rising Pharma Holdings, Inc. | None |
| 81033-241 | Lactulose Solution | solution | 10 g/15mL | Kesin Pharma Corporation | None |
| 81033-241 | Lactulose Solution | solution | 10 g/15mL | Kesin Pharma Corporation | None |
Questions
Is lactulose a controlled substance?
No. Lactulose is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and lactulose is not on the DEA controlled substances list.
Is lactulose a narcotic?
No. Lactulose is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Osmotic Laxative.
Does this page cover state schedules?
No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.
More on Lactulose
- What is Lactulose used for?FDA label uses
- Generic for ChronulacFDA Orange Book
- Generic for CephulacFDA Orange Book
- What is Enulose used for?FDA label uses
- Is Enulose a controlled substance?Federal schedule
- What is Constulose used for?FDA label uses
- Is Constulose a controlled substance?Federal schedule
- Osmotic Laxatives listFDA drug class
- NDC 0116-4005Lactulose NDC record
- NDC 0121-0873Lactulose NDC record
- NDC 0121-0965Lactulose NDC record