Duloxetine Hydrochloride NDC 50771-201

NDC codes

FDA NDC Directory

Product NDC (as listed)50771-201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50771-0201Add 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
50771-201-01	50771020101	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-201-01)Marketed from Jan 1, 2024

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 Hydrochloride
Generic name (nonproprietary): duloxetine hydrochloride
Active ingredients: Duloxetine hydrochloride — 20 mg/1
Dosage form: Capsule, Delayed release pellets
Route: Oral
Labeler: Yaopharma Co., Ltd.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207219
Marketing start: Jan 1, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 50771-201_5611fb30-bf39-7dae-e063-6294a90a08edSPL ID 5611fb30-bf39-7dae-e063-6294a90a08edSPL set ID 90224073-178d-7ec5-e053-2995a90a20fcRxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0350771203019, 0350771202012, 0350771201015
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

N450771020101 followed by a unit qualifier and the quantity

Package 50771-0201-01. 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 Jul 7, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Duloxetine delayed-release capsules, USP are indicated for the treatment of: • Major Depressive Disorder [see Clinical Studies ( 14.1 )] • Generalized Anxiety Disorder [see Clinical Studies ( 14.2 )] • Diabetic Peripheral Neuropathy [see Clinical Studies ( 14.3 )] • Chronic Musculoskeletal Pain [see Clinical Studies ( 14.5 )]

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207219

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

FDA NDC Directory listings under ANDA 207219
Product	Strength	Form · route	Labeler	Product NDC
Duloxetine Hydrochloride	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed release pelletsOral	Yaopharma Co., Ltd.	50771-203
Duloxetine Hydrochloride	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed release pelletsOral	Yaopharma Co., Ltd.	50771-202