Duloxetine Delayed-Release (duloxetine hydrochloride) NDC 51991-750

Product information

Brand name (proprietary)

Duloxetine Delayed-ReleaseSuffix: Delayed-Release

Generic name (nonproprietary)

duloxetine hydrochloride

Active ingredients

Duloxetine hydrochloride — 40 mg/1

Dosage form

Capsule, Delayed release pellets

Route

Oral

Labeler

Breckenridge Pharmaceutical, Inc.

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 203088

Marketing start

May 21, 2018

Listing expires

Dec 31, 2026

Other FDA classes

Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)

Identifiers

Product ID 51991-750_32327581-bdab-41ac-9adc-bf208e1c4e42SPL ID 32327581-bdab-41ac-9adc-bf208e1c4e42SPL set ID caef6f50-1571-4ec7-8f8c-42b924d323eeRxCUI 596926, 596930, 596934, 616402UNII 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

N451991075005 followed by a unit qualifier and the quantity Copy

Package 51991-0750-05. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 203088

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

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