Sertraline NDC 71610-769

Product information

Brand name (proprietary)

Sertraline

Generic name (nonproprietary)

sertraline

Active ingredients

Sertraline hydrochloride — 100 mg/1

Dosage form

Tablet, Film coated

Route

Oral

Labeler

Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 077397

Marketing start

Aug 20, 2012

Listing expires

Dec 31, 2026

Other FDA classes

Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)

Identifiers

Product ID 71610-769_13679124-92cd-bffa-e063-6394a90a219cSPL ID 13679124-92cd-bffa-e063-6394a90a219cSPL set ID 7be6a62e-0e85-47c8-8793-b41c51c2557fRxCUI 312938UNII UTI8907Y6X

Pharmacologic class

Serotonin 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

N471610076915 followed by a unit qualifier and the quantity Copy

Package 71610-0769-15. 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 71610-769

What is NDC 71610-769?

71610-769 is the product NDC for Sertraline, Sertraline hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sertraline.

What is the active ingredient?

Sertraline hydrochloride.

Who is the labeler?

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sertraline?

31 other product NDCs are listed under this name. See all Sertraline NDCs.

Is there a related HCPCS / J-code?

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

Related NDCs: other Sertraline products

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

All 32 Sertraline NDCs

Other NDCs under ANDA 077397

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

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