Duloxetine NDC 43547-380

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-380Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0380Add 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
43547-380-03	43547038003	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-380-03)Marketed from Jan 20, 2016
43547-380-09	43547038009	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-380-09)Marketed from Jan 20, 2016
43547-380-11	43547038011	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-380-11)Marketed from Jan 20, 2016

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: Solco Healthcare US, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206653
Marketing start: Jan 20, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 43547-380_ca41e20e-60e1-4134-83b8-e3b5f8732f4fSPL ID ca41e20e-60e1-4134-83b8-e3b5f8732f4fSPL set ID a105a648-6a97-4151-b9de-d7eac90a8f79RxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0343547380038, 0343547381035, 0343547379032
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

N443547038003 followed by a unit qualifier and the quantity

Package 43547-0380-03. 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 Dec 21, 2025. 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 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 ( …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206653

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

FDA NDC Directory listings under ANDA 206653
Product	Strength	Form · route	Labeler	Product NDC
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Solco Healthcare US, LLC	43547-379
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	Solco Healthcare US, LLC	43547-381
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-1964