LACTULOSE Crystalline (lactulose) NDC 85592-819

NDC codes

FDA NDC Directory

Product NDC (as listed)85592-819Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85592-0819Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
85592-819-30	85592081930	30 POUCH in 1 CARTON (85592-819-30) / 10 g in 1 POUCH (85592-819-01)Marketed from Sep 1, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): LACTULOSE CrystallineSuffix: Crystalline
Generic name (nonproprietary): lactulose
Active ingredients: Lactulose — 10 g/10g
Dosage form: Powder, For solution
Route: Oral
Labeler: Cumberland Assured Products Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074712
Marketing start: Sep 1, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 85592-819_ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9SPL ID ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9SPL set ID 59e75426-42ae-4904-941f-009181101a8aRxCUI 1251190, 1251194UNII 9U7D5QH5AEUPC 0385592829018, 0385592819019
Pharmacologic class: Osmotic Laxative

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N485592081930 followed by a unit qualifier and the quantity

Package 85592-0819-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Sep 1, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE LACTULOSE For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074712

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 074712
Product	Strength	Form · route	Labeler	Product NDC
Kristaloselactulose	Lactulose 10 g/10g	Powder, For solutionOral	Cumberland Pharmaceuticals Inc.	66220-719
Kristaloselactulose	Lactulose 20 g/20g	Powder, For solutionOral	Cumberland Pharmaceuticals Inc.	66220-729
Lactulose	Lactulose 10 g/10g	SolutionOral	Foxland Pharmaceuticals, Inc.	69067-010
Lactulose	Lactulose 20 g/20g	SolutionOral	Foxland Pharmaceuticals, Inc.	69067-020
LACTULOSE Crystallinelactulose	Lactulose 20 g/20g	Powder, For solutionOral	Cumberland Assured Products Inc.	85592-829