Lubiprostone NDC 65162-842

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-842Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0842Add 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
65162-842-06	65162084206	60 CAPSULE in 1 BOTTLE (65162-842-06)Marketed from Dec 3, 2021
65162-842-18	65162084218	180 CAPSULE in 1 BOTTLE (65162-842-18)Marketed from Dec 3, 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): Lubiprostone
Generic name (nonproprietary): lubiprostone
Active ingredients: Lubiprostone — 24 ug/1
Dosage form: Capsule
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209450
Marketing start: Dec 3, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Chloride Channel Activators (Mechanism)
Identifiers: Product ID 65162-842_8fcab8b3-47d1-4172-bd8e-7e89fe6daa25SPL ID 8fcab8b3-47d1-4172-bd8e-7e89fe6daa25
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

N465162084206 followed by a unit qualifier and the quantity

Package 65162-0842-06. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 209450

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

FDA NDC Directory listings under ANDA 209450
Product	Strength	Form · route	Labeler	Product NDC
Lubiprostone	Lubiprostone 8 ug/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-841