Duloxetine NDC 0615-8495

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

NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615

Product type

Prescription drug

Marketing category

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

Marketing start

Dec 11, 2013

Listing expires

Dec 31, 2027

Other FDA classes

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

Identifiers

Product ID 0615-8495_3ae078dc-e9a7-441a-b0c2-6ecdbb120a9dSPL ID 3ae078dc-e9a7-441a-b0c2-6ecdbb120a9dSPL set ID 54749431-430e-4532-97f7-4b1cd8dd252eRxCUI 596926, 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

N400615849505 followed by a unit qualifier and the quantity Copy

Package 00615-8495-05. 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

About NDC 0615-8495

What is NDC 0615-8495?

0615-8495 is the product NDC for Duloxetine, Duloxetine hydrochloride 30 mg/1 capsule, delayed release, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 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?

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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?

145 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 146 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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