Duloxetine NDC 80425-0441

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

Advanced Rx of Tennessee, LLCNDC labeler code 80425

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 090694

Marketing start

Oct 22, 2024

Listing expires

Dec 31, 2026

Other FDA classes

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

Identifiers

Product ID 80425-0441_25137bab-44cd-121d-e063-6394a90a2717SPL ID 25137bab-44cd-121d-e063-6394a90a2717SPL set ID 19afed24-39ad-daf1-e063-6394a90ad737RxCUI 596930, 596934UNII 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

N480425044101 followed by a unit qualifier and the quantity Copy

Package 80425-0441-01. 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

About NDC 80425-0441

What is NDC 80425-0441?

80425-0441 is the product NDC for Duloxetine, Duloxetine hydrochloride 30 mg/1 capsule, delayed release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Duloxetine.

What is the active ingredient?

Duloxetine hydrochloride.

Who is the labeler?

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 090694

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

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