duloxetine NDC 49252-009

NDC codes

FDA NDC Directory

Product NDC (as listed)49252-009Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49252-0009Add 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
49252-009-10	49252000910	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-10)Marketed from Dec 5, 2015
49252-009-11	49252000911	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-11)Marketed from Dec 5, 2015
49252-009-12	49252000912	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-12)Marketed from Dec 5, 2015
49252-009-18	49252000918	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-18)Marketed from Dec 5, 2015
49252-009-57	49252000957	100 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (49252-009-57)Marketed from Dec 5, 2015

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 — 60 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Inventia Healthcare Limited.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202336
Marketing start: Dec 5, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 49252-009_3fb45d3e-3fbc-8814-e063-6294a90a4a70SPL ID 3fb45d3e-3fbc-8814-e063-6294a90a4a70SPL set ID eab90059-ea1c-46c1-884d-c15e7c562a01RxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0349252007574, 0349252009103, 0349252008106, 0349252008571, 0349252009578
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

N449252000910 followed by a unit qualifier and the quantity

Package 49252-0009-10. 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 Sep 26, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Duloxetine is 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 USP is 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 pain (DPNP) in adults ( 1 ) Fibromyal…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202336

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

FDA NDC Directory listings under ANDA 202336
Product	Strength	Form · route	Labeler	Product NDC
duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Inventia Healthcare Limited.	49252-007
duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	Inventia Healthcare Limited.	49252-008
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	ANI Pharmaceuticals, Inc.	70954-860
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	ANI Pharmaceuticals, Inc.	70954-861
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	ANI Pharmaceuticals, Inc.	70954-864