Lactulose NDC 0121-0965

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0965Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0965Add 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
0121-0965-30	00121096530	30 POUCH in 1 CARTON (0121-0965-30) / 10 g in 1 POUCH (0121-0965-01)Marketed from Mar 17, 2025

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/10g
Dosage form: Powder, For solution
Route: Oral
Labeler: PAI Holdings, LLC dba PAI Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217914
Marketing start: Mar 17, 2025
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 0121-0965_78330d1b-d8d8-46ab-afcd-3a6362520db6SPL ID 78330d1b-d8d8-46ab-afcd-3a6362520db6SPL set ID 5ae4b6da-44df-419a-9f2b-8c4d79f635c8RxCUI 1251190, 1251194UNII 9U7D5QH5AE
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

N400121096530 followed by a unit qualifier and the quantity

Package 00121-0965-30. 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 Jul 7, 2026.

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)