Lactulose NDC 62135-003

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0003Add 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
62135-003-37	62135000337	237 mL in 1 BOTTLE, PLASTIC (62135-003-37)Marketed from Jan 10, 2021
62135-003-47	62135000347	473 mL in 1 BOTTLE, PLASTIC (62135-003-47)Marketed from Jan 10, 2021
62135-003-78	62135000378	3785 mL in 1 BOTTLE, PLASTIC (62135-003-78)Marketed from Jan 10, 2021
62135-003-94	62135000394	946 mL in 1 BOTTLE, PLASTIC (62135-003-94)Marketed from Jan 10, 2021

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: Chartwell RX, LLC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209517
Marketing start: Nov 23, 2018
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 62135-003_456e6761-40f8-db90-e063-6394a90a2393SPL ID 456e6761-40f8-db90-e063-6394a90a2393SPL set ID bd9f1577-65e8-4521-b176-e5fc60a4a018RxCUI 391937UNII 9U7D5QH5AEUPC 0362135003371, 0362135003944, 0362135003470
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

N462135000337 followed by a unit qualifier and the quantity

Package 62135-0003-37. 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 Dec 8, 2025.

Indications (excerpt from the label)

INDICATION 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 209517

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

FDA NDC Directory listings under ANDA 209517
Product	Strength	Form · route	Labeler	Product NDC
Lactulose	Lactulose 10 g/15mL	SolutionOral	Chartwell RX, LLC	62135-002
Lactulose	Lactulose 10 g/15mL	SolutionOral	Chartwell RX, LLC	62135-004
Lactulose	Lactulose 10 g/15mL	SolutionOral	Chartwell Governmental & Specialty RX, LLC.	68999-002
Lactulose	Lactulose 20 g/30mL	SolutionOral	Chartwell Governmental & Specialty RX, LLC.	68999-004