Duloxetine NDC 65841-800

NDC codes

FDA NDC Directory

Product NDC (as listed)65841-800Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65841-0800Add 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
65841-800-06	65841080006	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-800-06)Marketed from May 27, 2014
65841-800-10	65841080010	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-800-10)Marketed from May 27, 2014
65841-800-16	65841080016	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-800-16)Marketed from May 27, 2014

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): Duloxetine
Generic name (nonproprietary): duloxetine
Active ingredients: Duloxetine hydrochloride — 30 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Zydus Lifesciences Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090739
Marketing start: May 27, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 65841-800_22968719-7127-4aab-b4c4-4497de16ca23SPL ID 22968719-7127-4aab-b4c4-4497de16ca23SPL set ID f36b414e-ace4-4f04-a80f-75bb25db430dRxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0365841800166, 0365841801163, 0365841799163
Pharmacologic class: Serotonin and Norepinephrine Reuptake Inhibitor

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

N465841080006 followed by a unit qualifier and the quantity

Package 65841-0800-06. 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

Current FDA label (SPL), effective Nov 28, 2024.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090739

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

FDA NDC Directory listings under ANDA 090739
Product	Strength	Form · route	Labeler	Product NDC
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Zydus Lifesciences Limited	65841-799
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	Zydus Lifesciences Limited	65841-801