Duloxetine (Duloxetine hydrochloride) NDC 82009-031

Product information

Brand name (proprietary)

Duloxetine

Generic name (nonproprietary)

duloxetine hydrochloride

Active ingredients

Duloxetine hydrochloride — 40 mg/1

Dosage form

Capsule, Delayed release pellets

Route

Oral

Labeler

Quallent Pharmaceuticals Health, LLCNDC labeler code 82009

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 82009-031_c7833be1-34d9-43e4-8aff-966c14aa2798SPL ID c7833be1-34d9-43e4-8aff-966c14aa2798SPL set ID 31362045-201f-45f3-99f2-a5e322a0c30bRxCUI 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

N482009003190 followed by a unit qualifier and the quantity Copy

Package 82009-0031-90. 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

About NDC 82009-031

What is NDC 82009-031?

82009-031 is the product NDC for Duloxetine (duloxetine hydrochloride), Duloxetine hydrochloride 40 mg/1 capsule, delayed release pellets, listed with the FDA by Quallent Pharmaceuticals Health, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Duloxetine (Duloxetine hydrochloride).

What is the active ingredient?

Duloxetine hydrochloride.

Who is the labeler?

Quallent Pharmaceuticals Health, LLC, NDC labeler code 82009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Duloxetine?

140 other product NDCs are listed under this name. See all Duloxetine NDCs.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory. See Billing references above.

Related NDCs: other Duloxetine products

Other finished products listed under the same name: strengths, forms and labelers.

All 141 Duloxetine NDCs

Other NDCs under ANDA 203088

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

Showing 20 of 36.