What is NDC 65162-841?

65162-841 is the product NDC for Lubiprostone, Lubiprostone 8 ug/1 capsule, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lubiprostone?

37 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lubiprostone NDC 65162-841 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-841Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0841Add 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
65162-841-06	6516208410665162084106	60 CAPSULE in 1 BOTTLE (65162-841-06)Marketed from Dec 3, 2021
65162-841-18	6516208411865162084118	180 CAPSULE in 1 BOTTLE (65162-841-18)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 — 8 ug/1
Dosage form: Capsule
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
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 65162-841_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

N465162084106 followed by a unit qualifier and the quantity

Package 65162-0841-06. 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.

About NDC 65162-841

What is NDC 65162-841?: 65162-841 is the product NDC for Lubiprostone, Lubiprostone 8 ug/1 capsule, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lubiprostone.
What is the active ingredient?: Lubiprostone.
Who is the labeler?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lubiprostone?: 37 other product NDCs are listed under this name. See all Lubiprostone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lubiprostone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	American Health Packaging	60687-816	60687-0816-32
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	American Health Packaging	60687-827	60687-0827-32
Lubiprostone	Lubiprostone .008 mg/1	CapsuleOral	Northstar Rx LLC	72603-288	72603-0288-01
Lubiprostone	Lubiprostone .024 mg/1	CapsuleOral	Northstar Rx LLC	72603-289	72603-0289-01
Lubiprostone	Lubiprostone .008 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-403	31722-0403-60
Lubiprostone	Lubiprostone .024 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-404	31722-0404-60
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	Direct Rx	72189-607	72189-0607-60
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	SpecGx LLC	0406-6408	00406-6408-60
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	SpecGx LLC	0406-6424	00406-6424-60
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	Advanced Rx of Tennessee, LLC	80425-0354	80425-0354-02

All 38 Lubiprostone NDCs

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 24 ug/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-842