Lactulose NDC 83745-405

NDC codes

FDA NDC Directory

Product NDC (as listed)83745-405Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83745-0405Add 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
83745-405-16	83745040516	473 mL in 1 BOTTLE (83745-405-16)Marketed from Dec 20, 2024
83745-405-32	83745040532	946 mL in 1 BOTTLE (83745-405-32)Marketed from Dec 20, 2024

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
Generic name (nonproprietary): lactulose
Active ingredients: Lactulose — 10 g/15mL
Dosage form: Solution
Route: Oral
Labeler: APOZEAL PHARMACEUTICALS INC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207786
Marketing start: Dec 20, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 83745-405_da3c87b0-6781-4c58-83ca-1839cf914333SPL ID da3c87b0-6781-4c58-83ca-1839cf914333SPL set ID 72ac130a-de85-464d-9e9b-05cac0c54db1RxCUI 391937UNII 9U7D5QH5AEUPC 0383745405324, 0383745405164
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

N483745040516 followed by a unit qualifier and the quantity

Package 83745-0405-16. 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 Jul 23, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution 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)