Lactulose NDC 0116-4005

NDC codes

FDA NDC Directory

Product NDC (as listed)0116-4005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00116-4005Add 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
0116-4005-08	00116400508	237 mL in 1 BOTTLE (0116-4005-08)Marketed from Jul 1, 2022
0116-4005-10	00116400510	100 CASE in 1 CASE (0116-4005-10) / 40 TRAY in 1 CASE (0116-4005-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15)Marketed from Jul 1, 2022
0116-4005-11	00116400511	100 CASE in 1 CASE (0116-4005-11) / 40 TRAY in 1 CASE (0116-4005-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30)Marketed from Jul 1, 2022
0116-4005-15	00116400515	15 mL in 1 CUP, UNIT-DOSE (0116-4005-15)Marketed from Jul 1, 2022
0116-4005-16	00116400516	473 mL in 1 BOTTLE (0116-4005-16)Marketed from Jul 1, 2022
0116-4005-30	00116400530	30 mL in 1 CUP, UNIT-DOSE (0116-4005-30)Marketed from Jul 1, 2022
0116-4005-32	00116400532	946 mL in 1 BOTTLE (0116-4005-32)Marketed from Jul 1, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Xttrium Laboratories, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075911
Marketing start: Jul 1, 2022
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 0116-4005_4f6f0368-4b59-a9df-e063-6294a90ae43cSPL ID 4f6f0368-4b59-a9df-e063-6294a90ae43cSPL set ID df62ad54-5aba-4d05-e053-2a95a90aa48dRxCUI 391937UNII 9U7D5QH5AEUPC 0301164005086, 0301164005161, 0301164005321
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

N400116400508 followed by a unit qualifier and the quantity

Package 00116-4005-08. 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 Apr 14, 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)