Lubiprostone NDC 31722-403

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-403Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0403Add 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
31722-403-60	31722040360	60 CAPSULE in 1 BOTTLE (31722-403-60)Marketed from May 27, 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 — .008 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218640
Marketing start: May 27, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Chloride Channel Activators (Mechanism)
Identifiers: Product ID 31722-403_5008a4ec-08c5-4d06-bac9-e7239620a07dSPL ID 5008a4ec-08c5-4d06-bac9-e7239620a07dSPL set ID 6d973d7d-a43e-4495-b618-a8ad3142683dRxCUI 616578, 794639UNII 7662KG2R6KUPC 0331722404600, 0331722403603
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

N431722040360 followed by a unit qualifier and the quantity

Package 31722-0403-60. 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 Jan 22, 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 .024 mg/1	CapsuleOral	Northstar Rx LLC	72603-289
Lubiprostone	Lubiprostone .008 mg/1	CapsuleOral	Northstar Rx LLC	72603-288
Lubiprostone	Lubiprostone .024 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-404