Lubiprostone NDC 72603-289

NDC codes

FDA NDC Directory

Product NDC (as listed)72603-289Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72603-0289Add 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
72603-289-01	72603028901	60 CAPSULE in 1 BOTTLE (72603-289-01)Marketed from Jul 1, 2025

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): Lubiprostone
Generic name (nonproprietary): lubiprostone
Active ingredients: Lubiprostone — .024 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Northstar Rx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218640
Marketing start: Jul 1, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Chloride Channel Activators (Mechanism)
Identifiers: Product ID 72603-289_4d72c56c-4948-4cd4-afc4-e1e0d59622a5SPL ID 4d72c56c-4948-4cd4-afc4-e1e0d59622a5SPL set ID 1626ac65-ea12-421b-9780-bfdb50a39e1aRxCUI 616578, 794639UNII 7662KG2R6KUPC 0372603289015, 0372603288018
Pharmacologic class: Chloride Channel Activator

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

N472603028901 followed by a unit qualifier and the quantity

Package 72603-0289-01. 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 Jun 25, 2025.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Lubiprostone capsules is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. (1.1) opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1.2) o Limitations of Use: Effectiveness of lubiprostone capsules in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. (1.2, 7.1) irritable bowel syndrome with constipation (IBS-C) in women ≥18 years old. (1.3) 1.1 Chronic Idiopathic Constipatio…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218640

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

FDA NDC Directory listings under ANDA 218640
Product	Strength	Form · route	Labeler	Product NDC
Lubiprostone	Lubiprostone .008 mg/1	CapsuleOral	Northstar Rx LLC	72603-288
Lubiprostone	Lubiprostone .008 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-403
Lubiprostone	Lubiprostone .024 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-404