Duloxetine (duloxetine hydrochloride) NDC 25000-609

NDC codes

FDA NDC Directory

Product NDC (as listed)25000-609Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25000-0609Add 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
25000-609-03	25000060903	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-609-03)Marketed from May 27, 2022
25000-609-07	25000060907	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-609-07)Marketed from May 27, 2022

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 hydrochloride
Active ingredients: Duloxetine hydrochloride — 30 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: MARKSANS PHARMA LIMITED
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090723
Marketing start: May 27, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 25000-609_c8aa863f-eb1f-4b66-9ec6-2af2c7958248SPL ID c8aa863f-eb1f-4b66-9ec6-2af2c7958248SPL set ID 3686cde5-f76d-4d16-aa5d-caceb8408f8cRxCUI 596926, 596930, 596934UNII 9044SC542W
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

N425000060903 followed by a unit qualifier and the quantity

Package 25000-0609-03. 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 Oct 5, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Duloxetine delayed-release capsules are indicated for the treatment of: • Major depressive disorder in adults • Generalized anxiety disorder in adults and pediatric patients 7 years of age and older • Diabetic peripheral neuropathic pain in adults • Fibromyalgia in adults and pediatric patients 13 years of age and older • Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: • Major depressive disorder (MDD) in adults (1) • Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1) • Diabetic peripheral neuropathic pa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090723

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

FDA NDC Directory listings under ANDA 090723
Product	Strength	Form · route	Labeler	Product NDC
Duloxetineduloxetine hydrochloride	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	MARKSANS PHARMA LIMITED	25000-608
Duloxetineduloxetine hydrochloride	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	MARKSANS PHARMA LIMITED	25000-610