Lactulose NDC 55154-9448

NDC codes

FDA NDC Directory

Product NDC (as listed)55154-9448Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55154-9448Add 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
55154-9448-5	55154944805	5 CUP, UNIT-DOSE in 1 BAG (55154-9448-5) / 30 mL in 1 CUP, UNIT-DOSEMarketed from May 3, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 20 g/30mL
Dosage form: Solution
Route: Oral
Labeler: Cardinal Health 107, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074623
Marketing start: May 3, 2019
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 55154-9448_4b7d948c-1725-40ac-9582-76038e0c83edSPL ID 4b7d948c-1725-40ac-9582-76038e0c83edSPL set ID 3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd7RxCUI 391937UNII 9U7D5QH5AEUPC 0055154944854
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

N455154944805 followed by a unit qualifier and the quantity

Package 55154-9448-05. 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 May 19, 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)

Other NDCs under ANDA 074623

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

FDA NDC Directory listings under ANDA 074623
Product	Strength	Form · route	Labeler	Product NDC
Lactulose	Lactulose 10 g/15mL	SolutionOral	Proficient Rx LP	82804-107
Lactulose	Lactulose 10 g/15mL	SolutionOral	Atlantic Biologicals Corp.	17856-0874
Lactulose	Lactulose 10 g/15mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0873
Lactulose	Lactulose 20 g/30mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1746
Lactulose	Lactulose 10 g/15mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-4577
Lactulose	Lactulose 20 g/30mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1154